Bistos BT-300 User Manual
BT - 300
Fetal Monitor
BT-300
OPERATION MANUAL
Keep this manual for future reference
P/N : 300-ENG-OPM-EUR-R12
BT-300 Operation Manual 1
P/N : 300-ENG-OPM-EUR-R12
Bistos Co.,Ltd.
2019.07
Proprietary Material
Information and descriptions contained in this manual are the p roper ty 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 o ther rights of third parties that may res ult 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
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2019,07
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 ....................................................................................
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
9
4. BT-300 OPERATION .......................................................... 16
4.1 System Startup ............................................................................................... 16
4.1.1 Configuration Settings ......................................................................... 16
4.1.2 Under s tanding and Setting Alarms ...................................................... 17
4.1.3 Setting[Pint Speed/Fetal Movement Print/Auto Print/Dop2 Of fset/Record Enlarge] ......... 18
4.1.4 Setting Time and Date ......................................................................... 1
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
9
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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 Cidex
10. SPECIFICATIONS ............................................................ 32
TM
.................................................................................. 31
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 o f the BT-300 ................................................................................ 36
11.7 Request a service for general problems ....................................................... 36
12. Manufacturer’s Declaration.............................................. 37
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WARNING: Be informed that it may cause serious injury or death to the
CAUTION: Be informed that it may cause no harm in life but lead to
Section 1
Safety
1.1 Ins tructions 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 s upplied with the BT -300, or its equivalent, is
approved for use with the Unit.
Do not attempt to service the BT-300 monitor. Only qualifie d 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 defibrilla tor 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.
patient, property damage, and material losses against the “Warning” sign.
injury against the “Caution” sign.
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WARNING: EXPLOSION HAZARD — Do not use the BT-300 in a
other materials may occur.
WARNING: SHOCK HAZARD — The power receptacle must be a three
three-slot grounded outlet before attempting to operate the monitor.
WARNING: Do not connect to an electrical outlet controlled by a wall
WARNING: SHOCK HAZARD — Do not attempt to connect or
WARNING: Use only patient cables and transducers supplied with the
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 a ttempt to disjoint the power
to us first of all.
WARNING: SHOCK HAZARD — Do not touch the patient
ground. This can cause the electric shock to the patient or operator.
WARNING: SHOCK HAZARD — During upgr ading the BT-300, do not
patient.
WARNING: Use of accessories, transducers and cables other than those
immunity of this equipment and result in improper operation.
WARNING: Use of this equipment adjacent to or stacked with other
1.2 Warnings
flammable atmosphere where concentrations of flammable anesthetics or
wire grounded outlet. Never adapt the three-prong plug to fit a two-slot
outlet. If the outlet has only two slot s, make sure that it is replaced with a
disconnect a power cord with wet hands. Make certain that your hands are
clean and dry before touching a power cord.
monitor. Use of any other patient cables may result in out-of-specification
performance, possible safety hazards and electromagnetic safety problems.
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
simultaneously with contacting signal connector, other equipment or
use the BT-300 to the patient. This can cause the electric shock to the
specified or provided by the manufacturer of this equipment could result
in increased electromagnetic emissions or decreased electromagnetic
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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CAUTION: Keep the operating environment free of dust, vibrations,
CAUTION: The releva nt law restricts this device to sale by or o n the order
of a physician.
CAUTION: When installing the unit into a sealed place, allow for
visualization and operation. Two side of the device is must be opened.
CAUTION: Do not oper a te the unit if it is damp or wet because of
moving it from a cold environment to a warm, humid location.
CAUTION: Never use sharp or pointed objects to operate the front-panel
CAUTION:
General-purpose personal computers and modems are not
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
Follow cleaning and disinfection instructions in Section 9 of this manual.
CAUTION:
(Electromagnetic Compatibility Requirements)
WARNING: Medical electrical equipment needs special precautions
Otherwise, degradation of the performance of this equipment could result.
regarding EMC and needs to be installed and put into service according to
the EMC information provided in thi s manual. Portable RF
communications equipment (including peripherals such as antenna cables
and external antennas) should be use d no closer than 30 cm (12 inches) to
any part of the device, including cables specified by the manufacturer.
1.3 Cautions
-The equipment conforms to Class A according to IEC/EN 60601-1(Safety
of Electric Medical Equipmen t)
- This equipment conforms to Level B according to IEC/EN 60601-1-2
corrosive, or flammable materials, and extremes of temperature and
humidity. The unit should be kept clean and free of transducer gel and
other substances.
adequate ventilation, accessibility for servicing, and room for adequate
condensation or spills. Avoid using the equipment immediately after
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 no n-medical devices, which should be connected with a cable
of sufficient len gt h to prevent the non-medical equipment from contacting the
patient. If the BT-300 have to be connected another medical devices, it must
using solutions, us e s t er i l e wipes to avoid pouring flui ds directly on the transducer.
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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
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
damage to the device or electric shock.
external protective conductor in the installation or its arrangement is in
doubt, equipment shall be operated from its internal electrical source when
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
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Avoid placing in an
85%.
Do not disjoint or
responsibility of it.
Power off when
be damaged.
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.
area where there is a
high variation of
temperature.
Operating
temperature ranges
from 10°C to 40°C.
Operating humidity
ranges from 5% to
Avoid exposure to
direct sunlight
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 chemicals
are stored or where
there is in danger of
gas leakage.
disassemble the
equipment.
BISTOS Co., Ltd.
does not take
Avoid placing in
an area where
there is an
excessive shock
or vibration.
Avoid dust and
especially metal
material into the
equipment.
the equipment is
not fully installed.
Otherwise, the
equipment could
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Symbol
Description
This symbol id entifies a safe ty note. Ensur e you understan d the
is unknown hazardous po s sibility by ultrasound.
1.5 Definitions and Symbols
Power On/Off Button
function of this control before using it.
There are no note d or identified hazards by ultrasound. But there
External Signal IN/OUT P ort
Type BF Equipment
IPX8
※ According to IEC 60601-1-6 General requirements for basic safety and essential
performance – Collateral Standard : Usab ility, the d e finition and using these symbols
is adjusted.
IPX8 W a terpr oof
(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.
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WARNING: BT-350 is not intended for use d uring defibrillation, electr o-
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 tes ting and monitoring.
2.3 Intended Use
The BT-300 is a Prenatal Monitorin g System for non-invasive ly measuring a nd
showing gra phicall y 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 fi nal trime ster of pr egnancy (Non-Stress Test). T his device is for use
only by trained medical personnel located in hospitals, cli nics, doctor’s offices
and in the pa tient’s home.
2.4 Product Features
surgery, or magnetic resonance imaging (MRI).
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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Accessory
Name
Description
2.5 Options and Accessories
Ultrasound T ran sdu cer for Measuring
Doppler Probe
Pressure Sensor (Tocotonometer) for
UC Probe
Event Marker Used for a Fetal Movement event
(IPX8 : Waterp roof)
Measuring Uterine contraction
(IPX8 : Waterp roof)
FHR
AST Probe
(Option)
Z-folded type Paper Z-folder type thermal Paper
Probe Belt
Power Cord AC Power cord
Power Adaptor
LI-ION Battery 14.8V, 2 600mAh
Acoustic Stimulation
Test Probe
Used for Holding Doppler Probe
and/or UC Probe
Adaptor for transform AC Power
(100-240V ~) to DC 18V(2.8A)
Ultrasound Gel
Table 2.1. BT-300 Accesso ries
Ultrasound transmission gel
(Sanipia, ECOSONIC)
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① ② ③
④ ⑤⑥ ⑦ ⑧ ⑨ ⑩
⑬
⑫
⑪
⑭
Installation
3.1 Description of the BT-300 Front Panel
Section
3
Fig. 3.1 BT-300 Front Panel
① Power Indicating LED (AC:Green / Battery:Orang e)
② DOP 1 Connector
③ DOP 2 Connector(AST Connector)
④ UC Connector
⑤ Event Marker Connector
⑥ FHR & UC Value Display Panel
⑦ Heartbeat Lamp
⑧ DOP 1 Volume Up/Down Button
⑨ DOP 2 Volume Up/Down Button
⑩ UC Reference Button
⑪ Printer On/Off Button
⑫ Printer & Alarm LED
⑬ Alarm Sound On/Off Button
⑭ Print Door Open Button
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