Bistos BT-350 User Manual

P/N : OPM(BT-350)EN, Rev.06

BT-350 Operator Manual	1

Proprietary Material

Information and descriptions contained in this manual are the property of Bistos Corporation and may not be copied, reproduced, disseminated, or distributed without express written permission from Bistos Corporation.

Information furnished by Bistos Corporation is believed to be accurate and reliable. However, no responsibility is assumed by Bistos 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

Revision 06

April 2013

Copyright © Bistos Corporation 2013. All rights reserved.

7th Fl., A Bldg., Woolim Lions Valley 5-cha, 144-3,

Sangdaewon-dong, Jungwon-gu, Seongnam-si,

Gyeonggi-do, Korea

Telephone: ++82 31 750 0340

Fax: ++82 31 750 0344

Printed in Korea

P/N : OPM(BT-350)EN

www.bistis.co.kr

Rev. 06 (2013.04.12)

BT-350 Operator Manual	2

Table of Contents

1. SAFETY ..............................................................................		4
1.1	Instructions for the Safe Operation and Use of the BT-350 Monitor...............	4
1.2	Warnings..........................................................................................................	5
1.3	Cautions...........................................................................................................	5
1.4	Definitions 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-350 Front Panel...........................................................	11
3.2	Description of the Left Panel.........................................................................	12
3.3	Description of the Right Panel.......................................................................	12
3.4	Power On .......................................................................................................	13
3.5	Patient Cables ................................................................................................	13
3.6	Event Marker Cable.......................................................................................	13

4. BT-350 OPERATION ..........................................................			14
4.1	System Startup...............................................................................................		14
	4.1.1	Power-on Self-test ..........................................................................	14
	4.1.2	Configuration Settings ....................................................................	14
	4.1.3	Printer paper Select.........................................................................	15
4.2	BT-350 Monitor Display Screen....................................................................		16
	4.2.1	Mode Frame....................................................................................	17
	4.2.2	Heart Rate Numeric Frame .............................................................	17
	4.2.3	Heart Rate Graph Frame .................................................................	18
	4.2.4	UC Numeric Frame ........................................................................	18
	4.2.5	UC Graph Frame ............................................................................	18
	4.2.6	Power Status Frame ........................................................................	18
	4.2.7	Status Frame ...................................................................................	18
	4.2.8	Patient ID........................................................................................	19
	4.2.9	Time and Date.................................................................................	19
	4.2.10	Message Frame ...............................................................................	19
4.3	BT-350 Monitor Controls and Indicators.......................................................		20
4.4	BT-350 Monitor Contorl Knob ......................................................................		20

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4.5	Data Saving ...................................................................................................		21
	4.5.1 How to save data.............................................................................		21
4.6	Trend Mode ...................................................................................................		22
	4.6.1	Saved Time/Date Frame ...................................................................	22
	4.6.2	ID Frame...........................................................................................	22
	4.6.3	Data Searching Frame ......................................................................	22

5. RECORDER OPERATION .................................................		23
5.1	Loading Paper................................................................................................	23
5.2	Operation .......................................................................................................	24
6. MONITRING FETAL HEART RATE ...................................		26
6.1	Electromagnetic Interference.........................................................................	26
6.2	Detail Procedure ............................................................................................	28
7. UTERINE CONTRACTION(UC)............................................		30
7.1	Detail Procedure ............................................................................................	31
8. EVENT MARKER ...............................................................		32
8.1	Event Marker .................................................................................................	32
8.2	Clinical Event Marker ...................................................................................	32
9. CLEANING AND DISINFECTION ......................................		33
9.1	Monitor ..........................................................................................................	33
9.2	Transducers....................................................................................................	33
9.3	Belts...............................................................................................................	34
9.4	Contacting components and characteristics ...................................................	33
9.5	Description of CidexTM ..................................................................................	34
10.	SPECIFICATIONS ............................................................	35
11. TROUBLESHOOTING AND MAINTENANCE ....................		38
11.1	Self Test .......................................................................................................	38
11.2	Ultrasound Transducer Test .........................................................................	38
11.3	UC(TOCO) Test...........................................................................................	39
11.4 Battery Disposal and Handling ....................................................................		39
11.5	Maintenance.................................................................................................	39
11.6 Disposal of the BT-350 ................................................................................		39

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Section 1

Safety

1.1Instructions for the Safe Operation and Use of the BT-350 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-350, or its equivalent, is approved for use with the Unit.

Do not attempt to service the BT-350 monitor. Only qualified service personnel by Bistos Co.,Ltd. should attempt any needed internal servicing.

The BT-350 is not specified or intended for operation during the use of defibrillators or during defibrillator discharge.

The BT-350 is not specified or intended for operation in the presence of electrosurgical equipment.

The BT-350 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-350 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, 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-350 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 and possible safety hazards.

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-350, do not use the BT-350 to the patient. This can cause the electric shock to the patient.

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.

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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 cabinet, allow for adequate ventilation, accessibility for servicing, and room for adequate visualization and operation.

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-350 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-350 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-350 main body and trasducers 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: 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-350. This can cause the finger wound. Also do not prick the inside of BT-350 when the printer door is open. This can cause the damage to the device or electric shock.

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BT-350 Operator Manual	7

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		Avoidexposureto
	touch the equipment with wet		directsunlight
	hand.
	Avoid placing in an area
	where there is a high
	variation of temperature.		Avoid in the vicinity
	Operating temperature
			of Electric heater
	ranges from 10 C to 40 C.
	Operating humidity ranges
	from 20% to 90%.
	Avoid placing in an area		Avoid placing in
	where there is an		an area where
	excessive humidity rise or		thereisanexcessive
	ventilation problem.		shockorvibration.
	Avoid placing in an area		Avoid dust and
	where chemicals are		especially metal
	stored or where there is in		material into the
	danger of gas leakage.		equipment.
			Power off when
	Do not disjoint or		the equipment is
	disassemble the equipment.		not fully installed.
	BISTOS Co., Ltd. does not		Otherwise, the
	take responsibility of it.		equipment could
			be damaged.

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BT-350 Operator Manual	8

1.4Definitions 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 over 40 minutes.)
				Operating instructions
				When disposing of some components (ex: internal NiMH battery), do
				not dispose as general wastes.
				Adhere to all applicable laws regarding recycling.

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Section 2

Introduction

2.1General

This chapter provides a general description of the BT-350 monitor including:

Brief Device Description

Product Features

Model Configurations

2.2Brief Device Description

The BT-350 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-350 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.

2.4Product 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.

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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
							Adaptor for transform AC Power
				Power Adaptor			(100-240V ~) to DC 18V(2.5A)
							(MW160, Bridge Power Corp.)
							Type / model : GP270AAHC
				GP Battery			Technical data : 1.2V X 12ea, 2600mA
							(GP Batteries international Ltd.)
				Ultrasound Gel			Ultrasound transmission gel
							(Sanipia, ECOSONIC)
				Table 2.1. BT-350 Accessories

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Section 3

Installation

3.1Description of the BT-350LCD Front Panel

Fig. 3.1 BT-350LCD Front Panel

Power On/Off Button

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

TFT-Color LCD

Control Knob

Dop1 Volume Up/Down Button

Dop2 Volume Up/Down Button

Alarm Sound On/Off Button

UC Reference Button

Mode Change Button

Printer On/Off Button

Speaker

Print Door Open Button

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3.2Description of the Left Panel

Fig. 3.2 Left Panel

Power Adaptor Jack Connector

Event Marker Connector

RS-232C Port Connector

3.3Description of the Right Panel

Fig. 3.3 Right Panel

DOP1 Connector

DOP2 Connector

UC Connector

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