Bistos BT-350 User Manual

P/N: 350-ENG-OPM-EUR-R18

BT-350

Fetal Monitor

Operation Manual

BT-350, BT-350E

Keep this manual for future reference

Printed in Korea, July 2019

BT-350 Operation Manual

Contents

0. Safety information ·································································································· 3

0.1 General precautions, warnings, and cautions ········································································· 5

0.2 Shock hazards ···························································································································· 9

0.3 General precautions on environment ····················································································· 10

1. System basics ·········································································································· 11

1.1 Intended use ······························································································································ 11

1.2 Operating principle ···················································································································· 11

1.3 System configurations ·············································································································· 11

1.4 Product outlook ························································································································ 13

1.5 Description of system components ························································································· 14

1.6 Understanding the display ······································································································· 16

1.7 Essential performance ··············································································································· 19

2. Operation of BT-350·································································································· 20

2.1 System startup: self-test ·········································································································· 20

2.2 Buttons ····································································································································· 20

2.3 Control knob and system setting ······························································································· 21

2.4 Printer paper select ·················································································································· 23

2.5 Data saving ······························································································································· 24

2.6 Trend mode ································································································································ 25

2.7 CTG (Cardiotocography) analysis function ················································································ 25

2.8 CCV (Cross-channel verification) function ··············································································· 27

3. Operation of BT-350E ································································································ 29

3.1 Buttons ····································································································································· 29

3.2 Information messages ·············································································································· 29

3.3 Control knob and system setting ····························································································· 30

3.4 Data saving ······························································································································· 35

3.5 CCV (Cross-channel verification) function ··············································································· 36

4. Understanding alarms ····························································································· 37

5. Pinter ····················································································································· 38

5.1 Loading paper ··························································································································· 38

5.2 Printing ···································································································································· 38

6. Monitoring fetal heart rate ····················································································· 40

6.1 Electromagneic interference ···································································································· 40

6.2 Monitoring sequence overview ······························································································· 40

6.3 Detail procedure ······················································································································ 41

7. Uterine contraction (UC) ························································································· 43

7.1 Monitoring sequence overview ······························································································· 43

7.2 Detail procedure ······················································································································ 43

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BT-350 Operation Manual

8. Event marker ·········································································································· 45

8.1 Event marker ···························································································································· 45

8.2 Clinical event marker ··············································································································· 45

9. Cleaning and disinfection ························································································ 46

9.1 Monitor ···································································································································· 46

9.2 Probes ······································································································································ 46

9.3 Belt ··········································································································································· 47

9.4 Contacting components ··········································································································· 47

9.5 Description of Cidex

10. Specifications ·········································································································· 48

11. Troubleshooting and maintenance ·········································································· 51

11.1 Self-test ·································································································································· 51

11.2 Ultrasound transducer test ···································································································· 51

11.3 UC (TOCO) probe test ············································································································· 51

11.4 Battery ···································································································································· 52

11.5 Maintenance ·························································································································· 52

TM

·············································································································· 47

12. Manufacturer’s declaration on EMC ········································································ 53

12.1 Electromagneic emissions ······································································································ 53

12.2 Recommended separation distances between portable and mobile RF communications
equipment and BT-350 ··················································································································· 54

12.3 Electromagnetic immunity ····································································································· 55

Product warranty ·········································································································· 57

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BT-350 Operation Manual

Alerts you to a potential serious outcome, adverse event or safety

injury to the user or patient.

Alerts you to where special care is necessary for the safe and

serious injury.

Used to identify safety information.

During the operation, do not disconnect any cable.

0 Safety information

This manual is for trained healthcare professionals using the BT-350 fetal monitor. It describes
how to set up and use the monitor and transducers. Familiarize yourself with all instructions
including warnings and cautions before starting to monitor patients.

You should be:

 Trained in the use of fetal heart rate(FHR) monitors
 Trained in the interpretation of FHR traces.
 Familiar with using medical devices and with standard fetal monitoring procedures.

In this manual, the following symbols are used for the purpose of:

WARNING

hazard. Failure to observe a warning may result in death or serious

effective use of the product. Failure to observe a caution may

CAUTION

result in minor or moderate personal injury or damage to the
product or other property, and possibly in a remote risk of more

Symbols Used

The following symbols identify all instructions that are important for safety. Failure to follow these
instructions can lead to injury or damage to the fetal monitor. When used in conjunction with the
following words, the symbols indicate:

The following symbols are placed on product, label, packaging and this manual in order to stand for
the information about:

Be well-known this information thoroughly before using BT-350.

Power ON/OFF button

Indicates the need for the user to consult the instructions for use

External Signal IN/OUT port

IPX8

IPX8 Protected against the effects of continuous immersion in water (1 meter
of water for over 40 minutes)

Refer to the operation manual. Read the manual before placing the device.

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BT-350 Operation Manual

his symbol indicates the authorized representative in the European

This symbol indicates compliance with the essential requirements and

This symbol indicates to not dispose of the device together with

In order to comply with EU Directive 2002/96/EC on Waste Electrical and

This product may contain material which

DO NOT

be RECYCLED in accordance with local regulations, contact your local

Indicates the weight limit

This symbol indicates the manufacturer.

This symbol indicates the production date.

This symbol indicates the serial number of the device.

T
Community of the manufacturer.

This symbol indicates a type BF applied part.

This symbol indicates to keep the device dry.

This symbol indicates the correct upright position of a package

This symbol indicates the device is fragile.

This symbol indicates the temperature limitation for operation, transport,
and storage.

This symbol indicates the humidity limitation for operation, transport, and
storage.

This symbol indicates the packing material is recyclable.

provisions of the Medical Device Directive 93/42/EEC as amended by
2007/47/EEC.

unsorted municipal waste(for EU only). The solid bar symbol indicates
that the mains adapter is put on the market after 13 August 2005.

DISPOSAL

Electronic Equipment (WEEE):
could be hazardous to human health and the environment.
DISPOSE of this product as unsorted municipal waste. This product needs to

authorities for more information. This product may be returnable to your
distributor for recycling - contact the distributor for details.

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BT-350 Operation Manual

WARNING

BT-350 is not intended for use during defibrillation, electro-surgery, or

0.1 Before using the monitor

Fetal monitoring technology available today is not always able to differentiate a fetal heart rate (FH)
signal source from a maternal heart rate (MHR) source in all situations. Therefore, you should
confirm fetal life by independent means before starting to use the fetal monitor, for example, by
palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope,
or Pinard stethoscope. If you cannot hear the fetal heart sounds, and you cannot confirm fetal
movement by palpation, confirm fetal life using obstetric ultrasonography. Continue to confirm
that the fetus is the signal source for the FHR during monitoring.

Be aware that a MHR trace can exhibit features that are very similar to those of a FHR trace, even
including acceleration and decelerations. Do not rely solely on trace pattern features to identify a
fetal source.

It is possible to pick up maternal signal sources, such as maternal heart, aorta, or other large
vessels as the FHR. Misidentification may occur when the MHR is higher than normal (especially
when it is over 100 bpm).

Intended use

BT-350 fetal monitor is intended for non-invasive monitoring of fetal heart rates and
uterine activity. BT-350 is intended for generating alarms from fetal heart rate, for
displaying, storing and recording patient data and related waveforms.

BT-350 is intended for use by trained health care professionals.

BT-350 is intended for use in labor and delivery rooms and antepartum testing areas in
the hospital environment.



magnetic resonance imaging (MRI).

Indications for use

BT-350 is indicated for use by health care professionals for monitoring the fetal heart rate.

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BT-350 Operation Manual

0.2 General precautions, warnings and cautions

Before using BT-350, read all section of this manual carefully because there are additional
warnings and cautions which relate to specific features of the monitor.

The warnings and cautions in this section relate to the equipment in general and apply to all
aspects of the monitor. The listed order does not imply any order of importance.

Observe all precautions to ensure the safety of the patient and those near the instrument.

• 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

BT-350.

• Do not attempt to service the BT-350 monitor. Only qualified service personnel by Bistos Co.,

Ltd. should perform 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 ensure 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.

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BT-350 Operation Manual

WARNING

Thoroughly read and understand the manual prior to use of BT-350. Failure to do so

Check the rating of the power source compatible with the input voltage rating of the



could result in personal injury or equipment damage.

 Only properly trained personnel should use BT-350 as directed by an appropriately

qualified attending physician aware of currently known risks and benefits.

 This device has been validated with the accessories and options listed in this manual

and found to comply with all relevant safety and performance requirements
applicable to the device. It is, therefore the responsibility of that person or
organization who makes an unauthorized modification or incorporates an
unapproved attachment to the device.

 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.

 Use only certified accessories with the appropriate International Electrotechnical

Commission (IEC) 60601 harmonized standard.

 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.

 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

 Do not use in the presence of flammable anesthetics. Personal injury or equipment

damage could occur.

 Do not connect to an electrical outlet controlled by a wall switch.

 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.

 An operator may only perform maintenance procedures specifically described in this

manual.

 Do not remove the covers of BT-350 yourself to avoid damage to the equipment and

unexpected electric shock. Only qualified Bistos service engineer must repair BT-350
or replace a component.



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BT-350 Operation Manual

adapter.

Only use the supplied or appointed AC/DC adaptor.

CAUTION

The equipment conforms to Class I according to IEC/EN 60601-1(Safety of Electric

When the printer door is open, do not put the finger to the inside of BT-350. This can





Medical Equipment)

 This equipment conforms to Level B according to IEC/EN 60601-1-2 (Electromagnetic

Compatibility Requirements)

 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.

 When installing the unit into a cabinet, allow for adequate ventilation, accessibility for

servicing, and room for adequate visualization and operation.

 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.

 Never use sharp or pointed objects to operate the front-panel switches.

 General-purpose personal computers and modems are not designed to meet the

electrical safety requirements of medical devices. The RS-232C connector on the BT­350 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 with
other medical devices, it must comply with the standards IEC/EN 60601-1 and IEC/EN
60601-1-2.

 Do not autoclave or gas sterilize the monitor or any accessories. Follow cleaning and

disinfection instructions in Section 9 of this manual.

 Do not immerse BT-350 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.

 When washing the transducer belts, the water temperature must not exceed 60°C

(140°F).

 When loading paper, the paper must be put above the shaft. Otherwise, the paper

can be declined on one side.

 If the equipment is used in the 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.



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BT-350 Operation Manual

CAUTION

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

WARNING

Do not attempt to connect or disconnect a power cord with wet hands. Make

case of you have some problems with the power adaptor, we recommend that

Unplug the unit from its power source prior to cleaning or maintenance to

ome chemical cleaning agents may be conductive and leave a residue that

to contact electrical components and do not spray cleaning solutions onto any

d only into a properly

nit to excessive moisture that would allow for liquid

Due to the risk of electrical shock hazard, only qualified personnel with
appropriate service documentation should service the unit.

0.3 Shock hazards



sure that your hands are clean and dry before touching a power cord.

 Do not attempt to disassemble the power adaptor with no permission. It may

cause an electric shock. Also, it has a low possibility of reaching to death. In the

you have to contact to us first of all.

 During upgrading the BT-350, do not use the BT-350 on the patient. This can

cause an electric shock to the patient.



prevent personal injury or equipment damage.

 S

may permit a build-up of conductive dust or dirt. Do not allow cleaning agents

of these surfaces. Personal injury or equipment damage could occur.

 To ensure grounding reliability, plug the AC power cor

grounded 3-wire hospital-grade or hospital-use outlet. Do not use extension
cords. If any doubt exists as to the grounding connection, do not operate the
equipment. Personal injury or equipment damage could occur.

 Do not expose the u

pooling. Personal injury or equipment damage could occur.

 Do not touch the patient and signal input/output parts simultaneously



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BT-350 Operation Manual

0.4 General precautions 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 a wet hand.

Avoid placing in an area
where there is a high
variation of temperature.
Operating temperature
ranges from 10°C ~ 40°C.
Operating humidity ranges
from 5% ~ 85%.

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.

Do not disjoint or
disassemble the device.
Bistos Co., Ltd. does not
take responsibility for it.

Avoid placing in an area
where there is an excessive
shock or vibration.

Avoid dust and especially
metal material enter into
the equipment.

Power off when the
equipment is not fully
ready to operate.
Otherwise, the equipment
could be damaged.

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BT-350 Operation Manual

1 System basics

1.1 Intended use

BT-350, the non-invasive fetal monitoring system provides graphical and numerical information on fetal
heart rate (FHR) and maternal uterine activity (UA) to help assess fetal well-being before and during
labor. FHR often exhibits decelerations and accelerations in response to uterine contractions or fetal
movements; certain patterns are indicative of hypoxia. Examination of these patterns, the baseline
levels, and variability characteristics can indicate the need to alter the course of labor with drugs or
perform an operative delivery.

It is intended to be used to a pregnant woman only by trained and qualified personnel such as medical
professionals especially physicians and nurse of obstetrics in the medical institution having antepartum
examination rooms, labor, and delivery rooms.

1) Intended patient population

- Pregnant women

2) Intended user profile

- Nursing staff or physicians who is qualified

- Basic experiences or knowledge on the medical field, especially on obstetrics

- Trained or requested to read IFU before use

3) Environment of use

1. Hospital (birthing center, delivery rooms)

2. Requirements: Stable power source

1.2 Operating principle

The device detects the fetal heart rate and heartbeat sound using the Doppler effect of ultrasound and
measure the relative uterine contraction using the strain gauge and output the result to the printer.
The two probes are equipped to detect the fetal heart rate and heartbeat sound of twins.

The detection and measurement result can be displayed on the LCD (BT-350) or on LED (BT-350E).

1.3 System configurations

The basic configuration of BT-350

• Main body

• Two Doppler probes

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BT-350 Operation Manual

Accessory

Name

Description

• UC probe

Options of BT-350

• AST probe

• Li-ion Battery (14.8V, 2600mAh)

Doppler Probe

UC Probe

Ultrasound Transducer for Measuring FHR

(IPX8: Waterproof)

Pressure Sensor for Measuring Uterine contraction(UC)

(IPX8: Waterproof)

Event Marker Used for a Fetal Movement event

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)

Ultrasound Gel

AST Probe

(Option)

Ultrasound transmission gel

(Sanipia, ECOSONIC)

Acoustic Stimulation

Test P r obe

LI-ION Battery 14.8V, 2600mAh

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BT-350 Operation Manual

1.4 Product outlook

BT-350 BT-350E

Figure1-1: Front view

Left side view Right side view

Figure1-2: Side view

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BT-350 Operation Manual

1.5 Description of System components

14

BT-350 Operation Manual

Speaker

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

Control knob

DOP1 volume UP/DOWN button: Increase or decrease DOP1 fetal audio
volume in monitoring mode

DOP2 volume UP/DOWN button: Increase or decrease DOP2 fetal audio

Alarm sound ON/OFF button: Makes the alarm sound enable or disable

⑫

Print door open button

⑬

Printer door

7 segment LED Display(for BT-350E)

Event marker connector

③

RS-232C port

④

USB port

⑤

LAN port

No

①
②
③

④

⑤

⑥

⑦

⑧

⑨

⑩

⑪

⑭

Name & Description

TFT Color LCD

Power ON/OFF button: Turns the power On or Off

volume in monitoring mode

in monitoring mode

UC reference button: Resets the UC baseline in monitoring mode

Mode change button: The monitor operating mode change

Printer ON/OFF button: Turn the printer On or Off

①
②

Name & Description

Power adaptor jack connector

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BT-350 Operation Manual

②

DOP2/AST connector

③

UC connector

Name & Description

①

DOP1/AST connector

1.6 Understanding the display

1.6.1 BT-350 main monitoring screen display

1.6.1.1 Mode frame

The mode frame shows the current mode. There are monitoring mode, setup mode, and trend mode.

1.6.1.2 Patient ID frame

This frame displays patient identification. The monitor encodes the identification using the date to
ensure no duplication of IDs. The user may enter a patient name if desired.

Figure 1-3 – Main monitoring screen display (BT-350) – Graph mode

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BT-350 Operation Manual

1.6.1.3 FHR graph frame

The FHR graph frame displays a graphical representation of the FHR. The horizontal line is scaled
according to the printer paper setting (Refer to the “Printer paper select” chapter). The graph displays
4 minutes and 30 seconds of data.

This frame will show two heart rate trends when two ultrasound transducers are connected.

1.6.1.4 FHR numeric frame

The FHR numeric frame displays the fetal heart rate, a heart icon, and the volume icon. The heart rate
value displays the most recently calculated fetal heart rate. When a valid heart rate is detected, the
heart icon blinks at the measured heart rate interval. The volume icon indicates the current speaker
volume setting.

When the second ultrasound transducer is connected, the heart rate frame “US2” will display the fetal
heart rate, a heart rate icon, and the volume icon automatically. The trace-offset (DOP2 offset) icon
[+20] will also appear in the FHR frame if two ultrasound transducers are connected and ultrasound
trace offset (DOP2 offset) has been enabled.

1.6.1.5 UC (TOCO) graph frame

This frame displays the relative uterine contraction in graph form. The scale is from zero to 100 in
relative units. The graph displays 4 minutes and 30 seconds of data.

1.6.1.6 UC (TOCO) numeric frame

This frame displays the numerical value from the UC probe representing relative uterine contraction.
This frame also shows the present UC baseline value. A user can reset the baseline to 10.

1.6.1.7 Time/Date frame

This frame shows the current time and date and power source. The time and date can be changed. If
the device is operating using AC power then AC power icon is displayed. If the device is operating by
battery power, then a battery icon is displayed. The battery icon also displays charging status. If the
battery option is equipped selected, the internal battery is used when AC power disconnected.

The battery icon will flash when the battery is low (less than 10 minutes of remaining operating time).
If the battery is low (Low Battery) the printer will stop operating and the battery icon will turn to red.
The AC power should be connected to the device to charge the battery. The device will operate
normally while the AC power is charging the battery. The battery charging time is approximately 14
hours.

1.6.1.8 Status frame

This frame displays alarm status icon, printer status icon, printer speed set value, fetal movement set
status, auto printing status, save icon, and USB icon. The alarm icon is a bell. A diagonal line on the bell
indicates that alarm is disabled.

1.6.1.9 Message frame

This frame displays the error and current operation status. The error message will be displayed when

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