Bistos BT-350 User manual

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

BT-350 Operator Manual 1
P/N : OPM(BT-350)EN
www.bistis.co.kr
Rev. 06 (2013.04.12)
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., ABldg., 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

BT-350 Operator Manual 2
P/N : OPM(BT-350)EN
www.bistis.co.kr
Rev. 06 (2013.04.12)
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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Rev. 06 (2013.04.12)
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

BT-350 Operator Manual 4
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Rev. 06 (2013.04.12)
Section 1
Safety
1.1 Instructions 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 self-
test 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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1.2 Warnings
1.3 Cautions
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.
CAUTION: The relevant law restricts this device to sale by or on the order
of a physician.
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.
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)
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.

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Rev. 06 (2013.04.12)
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: 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-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.

BT-350 Operator Manual 7
P/N : OPM(BT-350)EN
www.bistis.co.kr
Rev. 06 (2013.04.12)
General Precaution on Environment
Do not keep or operate the equipment under the environment listed below.
Avoidplacing in an area
exposed tomoisture.Donot
touchtheequipmentwithwet
hand.
Avoidexposureto
directsunlight
Avoid placing in an area
where thereis ahigh
variation of temperature.
Operating temperature
ranges from 10Cto40C.
Operatinghumidityranges
from 20% to90%.
Avoid in thevicinity
of Electric heater
Avoidplacing in an area
where there is an
excessive humidityriseor
ventilationproblem.
Avoidplacing in
an area where
thereisanexcessive
shockorvibration.
Avoid placing in an area
where chemicals are
stored or where there is in
danger of gas leakage.
Avoid dustand
especiallymetal
materialinto the
equipment.
Do not disjointor
disassembletheequipment.
BISTOSCo.,Ltd. does not
takeresponsibilityof it.
Power off when
the equipment is
not fully installed.
Otherwise, the
equipment could
be damaged.

BT-350 Operator Manual 8
P/N : OPM(BT-350)EN
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Rev. 06 (2013.04.12)
1.4 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 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.

BT-350 Operator Manual 9
P/N : OPM(BT-350)EN
www.bistis.co.kr
Rev. 06 (2013.04.12)
Section 2
Introduction
2.1 General
This chapter provides a general description of the BT-350 monitor including:
Brief Device Description
Product Features
Model Configurations
2.2 Brief 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.
2.3 Intended 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.
2.4 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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2.5 Options and Accessories
Accessory
Name
Description
Doppler Probe
Ultrasound Transducer for Measuring
FHR
(IPX8 : Waterproof)
UC Probe
Pressure Sensor (Tocotonometer) for
Measuring Uterine contraction
(IPX8 : Waterproof)
Event Marker
Used for a Fetal Movement event
AST Probe
(Option)
Acoustic Stimulation
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(2.5A)
(MW160, Bridge Power Corp.)
GP Battery
Type / model : GP270AAHC
Technical data : 1.2V X 12ea, 2600mA
(GP Batteries international Ltd.)
Ultrasound Gel
Ultrasound transmission gel
(Sanipia, ECOSONIC)
Table 2.1. BT-350 Accessories

BT-350 Operator Manual 11
P/N : OPM(BT-350)EN
www.bistis.co.kr
Rev. 06 (2013.04.12)
Section 3
Installation
3.1 Description of the BT-350LCD Front Panel
Fig. 3.1 BT-350LCD Front Panel
①Power On/Off Button
②Power Indicating LED (AC:Green / Battery:Orange)
③TFT-Color LCD
④Control Knob
⑤Dop1 Volume Up/Down Button
⑥Dop2 Volume Up/Down Button
⑦Alarm Sound On/Off Button
⑧UC Reference Button
⑨Mode Change Button
⑩Printer On/Off Button
⑪Speaker
⑫Print Door Open Button
①
②
③
④
⑤
⑥
⑦
⑧
⑨
⑩
⑪
⑫

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3.2 Description of the Left Panel
Fig. 3.2 Left Panel
①Power Adaptor Jack Connector
②Event Marker Connector
③RS-232C Port Connector
3.3 Description of the Right Panel
Fig. 3.3 Right Panel
①DOP1 Connector
②DOP2 Connector
③UC Connector
②
③
①
②
③
①

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Rev. 06 (2013.04.12)
3.4 Power On
When the user wants to turn BT-350 on, power adaptor is connected with
power adaptor jack connector on left panel of BT-350 as shown in Figure 3.2
and power button is pressed.
3.5 Patient Cables
The ultrasound and TOCO transducer cable are connected to the right panel.
Each transducer has a label (DOP or UC) to insure proper connection to the
exact connector on the monitor. Also each connector in the right panel has a
label (DOP1 or UC) to insure proper cable connection.
The cables are connected or removed by putting into the connector tightly or
pulling out of the connector. There is no connector locking mechanism.
Another ultrasound transducer is supplied with the BT-350 capable of
monitoring two fetuses by connecting this to DOP2 connector.
3.6 Event Marker Cable
The event marker cable is connected to the connector in the left panel. The
label on the housing shows the location of the connector. The cable is
connected by putting into the connector tightly. There is no connector locking
mechanism.
WARNING: Use only patient cables and transducers supplied with the
monitor. Use of any other patient cables may result in out-of-specifications
performance and possible safety hazards.
WARNING: SHOCK HAZARD —Power receptacle must be a three -slot
grounded 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.

BT-350 Operator Manual 14
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Rev. 06 (2013.04.12)
Section 4
BT-350 Operation
4.1 System Startup
4.1.1 Power-on Self-test
The monitor performs a self-test each time it is turned on. This process allows
the monitor to check various systems for proper operation. The monitor displays
the startup screen during the power-on self-test. When the test is successfully
completed the BT-350 displays the monitoring screen.
If a malfunction is detected an error message displays and an error tone is
sounded. The error tone will continue until the power is turned off. If this occurs,
remove the monitor from service until appropriate action is taken.
Fig. 4.1 Self Test display
4.1.2 Configuration Settings
The monitor has several configuration settings that the user can change. Some of
these settings are reset to the default value each time the monitor is powered
down. Other parameter settings are saved in the monitor until the next time they
are changed. These parameters are unaffected when the monitor is powered
down. A complete list of these parameters is shown below.
Configuration parameter
Factory Default
Fetal Heart Rate Upper Alarm Limit
190 BPM
Fetal Heart Rate Lower Alarm Limit
110 BPM

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Configuration parameter
Factory Default
Dop2 Trace Separation
(Dop2 Offset)
0 BPM
FM Graph
OFF
Record Paper Speed
3 cm/min
Auto Printing
0 MIN
Patient Name
blank
Patient ID
Date/Sequential
number
Date
YY/MM/DD
Auto Save
OFF
Time
HH:MM:SS
Language
English
Paper
FS151-90-80R-01
4.1.3 Printer Paper Select
BT-350 is able to use two different types of papers. If you press control knob
during self test, you can see paper select menu as shown Figure 4.2. Rotating
control knob to choose paper type.
Fig. 4.2 Printer Paper Select
Paper
Graph Display Area
Print Area
FS151-90-80R-01
30-240 bpm
30-240 bpm
M1911A
50-210 bpm
50-210 bpm
CAUTION: If the inserted paper is different from the selected paper type,
the printed data will be incorrect. Be sure to check the selected paper type
is same as inserted paper.

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4.2 BT-350 Monitor Display Screen
Fig. 4.3 Main Monitoring Screen –Graph Mode
Fig. 4.4 Main Monitoring Screen –Number Mode
Press mode button [ ], then the relevant menu comes out as shown Figure 4.6.
Rotate the control knob to select the ‘Number Mode”or “Graph Mode”item.
Press the Control knob to change display-mode.
Symbol
Name
Description
Heart Rhythm Icon
Blinking according to heart rate
Alarm Sound Icon
Indicating of Alarm sound enable/disable

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Volume Icon
Indicating of the speaker volume setting for the
fetal echo sounds
Mute Icon
In case of volume level 0
Print Icon
Indicating of a printing status
Save Icon
Indicating of a data saving status
Print Speed Icon
Indicating print speed status
Auto Print Icon
Indicating of a status of auto printing function
AC Power Icon
Indicates the unit is operating on AC power
Battery Status Icon
Indicates the battery charge status
(Only when the BT-350 is operated by battery,
this icon is displayed.)
4.2.1 Mode Frame
The mode frame shows the current mode. There are monitoring mode, setup
mode and trend mode.
4.2.2 Heart Rate Numeric Frame (FHR Numeric Frame)
The heart rate (FHR) numeric frame displays the fetal heart rate, a heart icon,
alarm status icon, and a speaker volume icon. This channel is labeled “US1.”
The heart rate value shows the most recent calculated fetal heart rate. The heart
rate icon blinks at the measured heart rate interval when a valid rate is present.
The volume icon provides an indication of the speaker volume setting for the
fetal echo sounds. This icon changes when the volume setting is adjusted. The
alarm icon is a bell. A diagonal line through the bell indicates alarms are
disabled. A bell missing a diagonal line indicates alarms are enabled.
When the second ultrasound transducer is connected, the heart rate frame will
include additionally the fetal heart rate, a heart rate icon, alarm status icon, and a
speaker volume icon for the second ultrasound channel. This channel is labeled
“US2.”
The trace-offset (DOP2 offset) icon will also appear in the heart rate frame if two
ultrasound transducers are connected and ultrasound trace offset (DOP2 offset)
has been enabled. The trace-offset icon is “ +20”.

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4.2.3 Heart Rate Graph Frame (FHR Graph Frame)
The Heart Rate (FHR) Graph Frame displays a graphical representation of the
fetal heart rate. The vertical scale is labeled and corresponds to the recorder
paper (30 to 240 BMP). The graph displays 4 minutes and 30 seconds of data
regard less of print speed.
This frame will show two heart rate trends when two ultrasound transducers are
installed.
Three horizontal graticules are included to make it easier for the caregiver to
observe heart rate trend or heart rates that exceed limits. The position of these
three graticules is 100 BPM, 140 BPM and 180 BPM.
This graphical frame is also used to display heart rate data when scrolling
through historical patient data.
4.2.4 UC Numeric Frame(TOCO Numeric Frame)
This frame contains the numeric value from the UC transducer representing
uterine contraction. This frame also shows the present UC baseline value. The
UC baseline is user adjustable.
4.2.5 UC Graph Frame(TOCO Graphic Frame)
The UC Graph Frame displays uterine contraction graph data. The scale is from
zero to 100 in relative units. The graph displays 4 minutes and 30 seconds of
data regardless of print. This graphical frame also displays uterine contraction
data when scrolling through patient data.
4.2.6 Power Status Frame
This frame contains either a battery icon or an AC power connector icon. If the
unit is operating on AC power then an AC power connector icon is displayed. If
the monitor is operating on internal battery power then a battery icon is displayed.
The battery icon also includes a scale indicating battery charge status. If AC
power is disconnected, BT-350 uses the internal battery. Therefore in the case of
AC power is disconnected, there is no problem to use BT-350.
The battery icon will flash when the battery is low (less than 10 minutes of
remaining time). The AC power should be connected to the monitor to charge
the battery. The monitor will operate normally while the AC power is charging
the battery. The battery will be fully recharged in 14 hours if the monitor is not
in use, or in 14 hours while in normal use.

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4.2.7 Status Frame
This frame shows printer speed set, printer operating status, zoom in status, auto
printing status, and saving status.
4.2.8 Patient ID
This section displays the patient identification. The monitor uses a time and date
encoded identification scheme that insures no duplication of names. The user
may also enter a different name if desired.
4.2.9 Time and Date
This frame shows the current time and date for the monitor. These settings can
be changed as needed.
4.2.10 Message Frame
This frame shows the error and current operation status. The error message will
be displayed when the monitor is unable to operate properly. If this error
message shows, discontinue use of monitor.
Message
Description
DOP1 OPEN
DOP1 is not connected
while BT-350 is monitoring
DOP2 OPEN
DOP2 is not connected
while BT-350 is monitoring
DOOR OPEN
Print door is opened while BT-350 is
printing
No PAPER
Paper is not loaded while BT-350 is
printing
LOW BAT
Battery’s charging level is low
while BT-350 is monitoring