Bistos BT-350 User Manual

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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

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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

·············································································································· 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

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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

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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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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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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Message

Description

Symbol

Name

Description

Indicating the speaker volume setting for the fetal echo

sounds

Indicates the battery charge status (Only when the BT-

350 is operated by battery, this icon is displayed.)

the device is unable to operate properly. If this error message displayed, stop using the device and check.

DOP1 OPEN DOP1 is not connected while BT-350 is monitoring

DOP2 OPEN DOP2 is not connected while BT-350 is monitoring

DOOR OPEN Printer 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

Figure 1-4 – Main monitoring screen display (BT-350) – Number mode

Heart Rhythm Icon Blinking according to heart rate

Alarm Sound Icon Indicating of Alarm sound enable/disable

Volume Icon

Mute Icon In the case of volume level 0

Print Icon Indicating a printing status

Save Icon Indicating a data saving status

Print Speed Icon Indicating print speed status

Auto Print Icon Indicating of the status of the auto printing function

AC Power Icon Indicates the unit is operating on AC power

Battery Status Icon

USB Icon Indicating USB connection status.

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Display

Description

Alarm

Indicating of Alarm sound enable/disable

USB

Indicating of USB record status

US +20

Indicating of US2 offset enable/disable

1.6.2 BT-350E main monitoring screen display

Figure 1-5 – Main monitoring screen (BT-350E)

1.6.2.1 Heart Rhythm

The heart symbol is turned on according to FHR value. If FHR value is out of normal range (30 ~ 240), the heart symbol is turned off.

1.6.2.2 FHR/UC frame

The FHR frame displays the detected fetal heart rate. When the second ultrasound transducer is connected, the “US2” frame will display the fetal heart rate too.

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.

1.6.2.3 Status frame

This frame shows the BT-350 LED status.

Print Indicating a printing status

1.7 Essential performance

1) Accuracy of fetal heart rate

The accuracy for the FHR should be within +/- 2% at the range 30 to 240 BPM.

2) The display range of UC

The display range of the UC is from 0 to 100.

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CAUTION

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

Symbol

Name

Description

Decreases or increases Dop1 fetal audio volume in

Decreases or increases Dop2 fetal audio volume in

Makes the alarm sound enable or disable in monitoring

2 Operation of BT-350

2.1 System startup: 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-onself-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 use until appropriate action is taken.

Fig. 2.1 Self-test display

2.2 Buttons

There are seven buttons located on the front panel. The buttons are activated by pushing with the finger until an audible click sound is heard.



The operation of the button is as below.

Power On/Off Button Turns the power on or off.

Dop1 Volume

Up/Down Button

Dop2 Volume

Up/Down Button

monitoring mode.

Alarm On/Off Button

mode.

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Puts the monitor into trend scroll mode. The trend frames show historical patient data and the control knob provides navigation capability.

Parameter

Factory Default

Dop2 Trace Separation (Dop2 Offset)

0 BPM

FM Graph

OFF

Printing Speed

3 cm/min

Auto Printing

0 MIN

Patient Name

blank

Patient ID

Date/Sequential number

Date

YY/MM/DD

Time

HH:MM:SS

Auto Save

OFF

Language

English

Paper

FS151-90-80R-01

UC Reference Button Resets the UC baseline in monitoring mode.

Mode Button

Record On/Off Button Turns the record on or off.

2.3 Control knob and system setting

Use the control knob to select the parameter to change and to adjust the parameter value selected.

Press down the knob activates the setup menu as shown in Fig.2.2. Turn the knob clockwise or counterclockwise to move the cursor and press down it to select the parameter. Turn the knob to change the value and press down to store the value. The basic operation sequence is summarized in the below table. Select “ESC” and press down the knob to save the exit setup menu.

Fig. 2.2 System setup menu

The monitor has several configuration settings that the user can change. These parameters are unaffected when the monitor is powered down. Below is the default setting value of parameters.

Fetal Heart Rate Upper Alarm Limit 190 BPM

Fetal Heart Rate Lower Alarm Limit 110 BPM

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Activity

Desired Result

Press down

Enter the setup menu

Rotate

Move the cursor

Press down

Select the parameter to change.

Rotate

Change the value

Press down

Store the new value.

The basic operation of the control knob to parameter settings is as follows.

2.3.1 Alarm upper limit/lower limit set

The upper and lower alarm limit can be changed. The adjustable range for upper limit is [Lower limit +10] ~ 240 BPM with 5 BPM step. The adjustable range for a lower limit is 30 ~ [Upper limit – 10] BPM with 5 BPM step.

2.3.2 DOP2 offset set

The two waveforms for each Doppler transducer can be separated to prevent some confusing and enable to see the waveform clearly. When ultrasound trace separation is enabled, the trend data for ultrasound channel 2 is shifted up by 20 BPM in printing. This feature is useful when both heart rates waveforms are similar. The heart rate value shown in the numeric frame is not affected. If DOP2 offset is selected, [+20] is displayed in US2 numeric frame.

2.3.3 Fetal movement (FM) graph

The fetal movement graph display can be turned on and off.

2.3.4 Printing speed

The printing speed can be selected among 1cm/min, 2cm/min, and 3cm/min.

2.3.5 Auto printing

The printer can be turned off automatically. If the value is set to 0, the printer will print out until the paper ended. If the value is set to 10, the printer will turn off after 10 minutes. You can choose among 0, 10, 20, 30, 40, 50, and 60.

2.3.6 Entering the patient name

You can enter a patient name if required. If you select the [NAME] item, you can see the following display to enter the name. If you want to enter the second character of the selected character set, you can press down the knob twice. For example, D requires one press down and F requires three press down.

.QZ ABC DEF GHI JKL MNO

PRS TUV WXY

ESC

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BT-350 Operation Manual

M1911A

50-210 bpm

2.3.7 Entering the patient ID

Patient ID is generated automatically when BT-350 has turned on. This ID is composed of YYMMDD + 3 digits serial number. The 3 digits number can be changed manually.

2.3.8 Set date and time

Set the date and time if required. Enter date in the YY/MM/DD format and time in the 24 hours format.

2.3.9 Set auto save

You can save the measured data manually or automatically. If [AUTO SAVE] function activates, all the measured data is stored from the power on. The default value for this function is OFF.

2.3.10 Set language

The default language setting is English. You can choose among English, Chinese, Spanish, German, French, Indonesian, Russian, Portuguese, Turkish, Polish, Italian, Korean, Japanese, and Serbian.

2.3.11 CMS (Central monitoring system) settings

You can change the communication channel, IP address, subnet address, gateway address, port address, and HRV (Heart Rhythm Variability) sensitivity. You can choose the communication channel between Serial and Ethernet. And you can choose the HRV sensitivity among low, middle, and high. You can enter a value for other parameters.

2.4 Printer paper select

You can use two different types of paper, FS151-90-80R-01 and M1911A, with BT-350. If you press down the control knob during the self-test, you can select the printer paper.

Fig. 2.3 Printer paper select

Paper Graph Display Area Print Area

FS151-90-80R-01 30-240 bpm 30-240 bpm

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BT-350 Operation Manual

CAUTION

If you use a different type of paper from the selected paper type, the printed data will be

changed to 110.



incorrect. Be sure to check the selected paper type is the same with used paper.

 When paper type is changed, the alarm upper limit is changed to 190 and alarm lower limit is

2.5 Data saving

The measured data can be saved to the monitor itself and USB, if connected, at the same time. For each patient, up to 3 hours of data can be saved. Totally 450 hours of data can be saved. The saved data can be totally copied moved from BT-350 to USB memory later.

2.5.1 How to save data

Press down the mode button [ ] to activate the following menu.

Fig. 2.4 Save Date display

Select [Save Date] item and press down the control knob to start the saving function. If the save function activated save icon [ ] is activated by yellow color and rotate. Press down the mode button

[ ] to finish data saving. If the USB memory is connected, the USB icon activated by yellow color and data saved to USB memory simultaneously.

2.5.2 How to copy the saved data to USB

Press down the mode button [ ] to activate menu while USB memory has connected. Select “Trend Mode”. Turn the control knob to select USB and the USB will turn to red color. Then press down the control knob to copy the saved data to USB memory.

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Button

Function

Searching for saved data by patient ID. Selecting Previous / Next Patient

Searching for saved data by saved page. Selecting Previous / Next Page

Fig. 2.5 Trend mode display

2.6 Trend mode

In trend mode, you can see the saved data. Press down the mode button [ ] to activate the menu shown in figure 2.4. Rotate the control knob to select the “Trend Mode”. Press down the control knob to enter the trend mode.

The data saved date and time and the relevant patient ID are displayed. You can search for data by a patient or by page and tracing saved graphic data.

Tracing the saved graphic data

2.7 CTG (Cardiotocography) analysis function

The CTG analysis function is a computerized diagnosis of fetal heart rate and uterine contraction patterns.

When this function is activated, a CTG algorithm monitors continuous FHR and UC value for 20 minutes and analyzes FHR variability and relative FHR response to UC change.

To activate this function, press down the control knob during self-test for 4 times and then the following menu will be displayed.

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Fig. 2.6 CTG analysis function

After selecting ON the CTG analysis function, you can use this function by pressing the [Print] button in the monitoring mode. On pressing the [Print] button, the mode will change from <Monitoring Mode> to <CTG Mode> and the printing will be started. On the FHR frame, the <Baseline Value> will be displayed.

Fig. 2.7 CTG mode

When you press down the [Print] button again after more than 20 minutes elapsed, printing will be stopped and CTG analysis will be ended. The analysis result will be displayed and printed.

Fig. 2.8 CTG results in monitoring mode

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BT-350 Operation Manual

Fig. 2.9 CTG result in trend mode

2.8 CCV (Cross-channel verification) function

When monitoring two fetuses with two Doppler probes, CCV function will compare the values from both probes and alerts when the values could be the same source (fetus).

If the difference between two probe values is within 2 bpm for more than 25 seconds during 30 seconds monitoring period, CCV alert will be generated and icon will be displayed.

To activate this function, press down the control knob during self-test for 3 times and then the following menu will be displayed.

Fig. 2.10 CCV function

Fig. 2.11 CCV displayed

If the CCV appears during printing the data, icon will be printed on the paper.

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Fig. 2.12 CCV printed

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BT-350 Operation Manual

CAUTION

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

Symbol

Name

Description

Decreases or increases Dop1 fetal audio volume in

Decreases or increases Dop2 fetal audio volume in

Puts the monitor into trend scroll mode. The trend

provides navigation capability.

Message

Description

3 Operation of BT-350E

3.1 Buttons

There are seven buttons located on the front panel. The buttons are activated by pushing with the finger until an audible click sound is heard.



The operation of the button is as below.

Power On/Off Button Turns the power on or off.

Dop1 Volume

Up/Down Button

Dop2 Volume

Up/Down Button

Alarm On/Off Button

UC Reference Button Resets the UC baseline in monitoring mode.

Mode Button

Record On/Off Button Turns the record on or off.

monitoring mode.

Makes the alarm sound enable or disable in monitoring mode.

frames show historical patient data and the control knob

3.2 Information messages

The following messages are displayed to indicate the error and current operation status. The error message is displayed when the monitor is unable to operate properly. If the error message is showing up, stop using BT-350E and take appropriate action.

DOP1 OPEN. Doppler probe is not

connected to DOP1 connector

DOP2 OPEN. Doppler probe is not

connected to DOP2 connector.

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BT-350 Operation Manual

Message

Description

Parameter

Factory Default

Fetal Heart Rate Upper Alarm Limit

190 BPM

Fetal Heart Rate Lower Alarm Limit

110 BPM

Dop2 Trace Separation (Dop2 Offset)

0 BPM

FM Graph

OFF

Printing Speed

3 cm/min

Auto Printing

0 MIN

Paper

FS151-90-80R-01

Activity

Desired Result

Press down

Enter the setup menu

Rotate

Move the cursor

Press down

Select the parameter to change.

Rotate

Change the value

Press down

Store the new value.

DOOR OPEN. The print door is opened.

NO PAPER. Paper is not loaded

LOW BATTERY. Battery charging level is

low

3.3 Control knob and system setting

Use the control knob to select the parameter to change and to adjust the parameter value selected.

The monitor has several configuration settings that the user can change. These parameters are unaffected when the monitor is powered down. Below is the default set of parameters.

The basic operation of the control knob to parameter settings is as follows.

3.3.1 Alarm upper limit/lower limit set

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BT-350 Operation Manual

Fig. 3.1 Alarm Upper /Lower Limit

3.3.2 DOP2 offset set

Fig. 3.2 DOP2 offset

3.3.3 Set date and time

Set the date and time if required. Enter date in the YY/MM/DD format and time in the 24 hours format.

Fig. 3.3 Date and time

3.3.4 Printing speed

The printing speed can be selected among 1cm/min, 2cm/min, and 3cm/min.

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BT-350 Operation Manual

Paper

Graph Display Area

Print Area

M1911A

50-210 bpm

Fig. 3.4 Printing speed

3.3.5 Auto printing

Fig. 3.5 auto printing

3.3.6 Fetal movement (FM) graph

The fetal movement graph display can be turned on and off.

Fig. 3.6 Auto printing

3.3.7 Printer paper select

You can use two different types of paper, FS151-90-80R-01 and M1911A, with BT-350. If you press down the control knob during the self-test, you can select the printer paper.

FS151-90-80R-01 30-240 bpm 30-240 bpm

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BT-350 Operation Manual

CAUTION

If you use a different type of paper from the selected paper type, the printed data will be

changed to 110.

Fig. 3.7 Printer paper select



incorrect. Be sure to check the selected paper type is the same with used paper.

 When paper type is changed, the alarm upper limit is changed to 190 and alarm lower limit is

3.3.8 CCV On/Off

When monitoring two fetuses with two Doppler probes, CCV function will compare the values from both probes and alerts when the values could be the same source (fetus).

If the difference between two probe values is within 2 bpm for more than 25 seconds during 30 seconds monitoring period, CCV alert will be generated and icon will be displayed.

This CCV function can be on and off.

Fig. 3.8 CCV function select

3.3.9 CMS (Central monitoring system) communication channel

CMS communication channel can be selected between serial and Ethernet.

Fig. 3.9 CMS communication channel

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3.3.10 IP address set

Set the IP address as required.

Fig. 3.10 IP address set

3.3.11 Subnet mask set

Set the subnet mask as required.

3.3.12 Gateway set

Set the gateway as required.

Fig. 3.11 Subnet mask set

Fig. 3.12 Gateway set

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BT-350 Operation Manual

3.3.13 Port number set

Set the port number as required.

Fig. 3.13 Port number set

3.3.14 HRV (Heart Rate Variability) sensitivity set

Set the HRV sensitivity as required.

Fig. 3.14 HRV sensitivity set

3.4 Data saving

The measured data can be saved to the USB memory.

After connecting USB memory to BT-350E, press down the mode button [ ] to activate the data saving function. The USB data saving indicator will be lit and the “ding-dong” sound will be generated.

Fig. 3.15 USB data saving function activated

Press down the mode button [ ] to finish data saving. The USB data saving indicator will be turned off and the “ding-dong” sound will be generated.

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3.5 CCV (Cross-channel verification) function

When monitoring two fetuses with two Doppler probes, CCV function will compare the values from both probes and alerts when the values could be the same source (fetus).

If the difference between two probe values is within 2 bpm for more than 25 seconds during 30 seconds monitoring period, CCV information sound will be generated

When the difference between two probe values is more than 2 bpm for more than 5 seconds, the CCV information sound will be turned off and BT-350E will be operating normally.

If the CCV appears during printing the data, icon will be printed on the paper.

Fig. 3.16 CCV printed

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BT-350 Operation Manual

Repetition

Interval

1. Power on

oor is opened

6. Complete auto printing

4 Understanding alarms

The monitor will generate an alarm when the FHR exceeds the set alarm limits. But these limits have no significant meaning in clinical uses.

One time exceeding the limits will not generate the alarm. If the alarm condition (exceeding the limits) endures for more than 20 seconds the alarm sound will be generated and the red led is flashing with the heart rate value on display will be blinking as long as the alarm condition persists or alarm is disabled by the user. Pressing the alarm button on the monitor’s keypad can silence the alarm tone.

Alarms are enabled or disabled by pressing the alarm button on the keypad.

Classification Frequency/Sound

Upper

alarm

sound

Alarm Sound

Lower

alarm

sound

Information

sound

3 seconds

2 seconds

Situation

When FHR exceeds Upper Limit value over 20 seconds

When FHR goes down Lower Limit over 20 seconds

2. DOP1 or DOP 2 is

disconnected while BT350 is monitoring.

3. Paper is out while BT-

350 is printing.

4. Printer d

while BT-350 is printing.

5. Battery’s charge level is

low while BT-350 LED is monitoring.

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BT-350 Operation Manual

5 Printer

5.1 Loading paper

Open the printer door by pressing down the [Printer door open button]. Unwrap a pack of paper and put it into the paper tray.

A page from the top of the paper pack should drape forward over the shaft of the printer. The orientation of the paper is with the printed grid facing up (unfolding from the top of the pack) and the UC grid area is the right side.

Fig. 5.1 Loading paper

5.2 Printing

Print On/Off button — Press the print button [ ] to start printing. Press again to stop printing.

Paper Advance — Press and hold the print button [ ] to fast-forward the paper.

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BT-350 Operation Manual

Press Event marker

woman)

(by a doctor)

FM1 Trace

automatic)

FM2

automatic)

FHR Tra c e

Situation

FM Tr a c e

UC Trace

Symbol Description Source of mark Possible events

Event Mark

Clinical Event Mark

FM1 Detection Mark

FM2 Detection Mark

AST Mark

Fig. 5.2 Printing result

(by a pregnant

Press [ ] button

over 2 seconds

(by algorithm and

AST

(by a doctor)

When doctor judges fetus movement

When a pregnant woman feels fetus

movement

happens

When the system detects fetus

movement(FM1)

When the system detects fetus

movement(FM2)

When the system detects AST signal

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CAUTION

The cable of the Doppler probe is not intended to contact the patient. To prevent such contact,

with clean gauze or fabric.

6 Monitoring fetal heart rate

6.1 Electromagnetic interference

Strong electromagnetic fields can interfere with the ultrasound transducer and cause a false heart rate reading that does not originate from the fetus. This interference is rare and usually found in the vicinity of large machinery. In order to avoid the possibility of these interferences, the following procedure should be followed whenever the monitor is to be used in a new location, or if it is known that electrical machinery is being operated in the vicinity.

After connecting the ultrasound transducer(s), turn on the monitor and observe the heart rate indications on the screen for 30 seconds. Intermittent display of random heart rate is acceptable. However, if there is a constant display of a physiological heart rate lasting more than 5 seconds, this is an indication that there is a source of electromagnetic interference in the vicinity. The following steps should be taken to determine if it is possible to use the monitor in this environment.

 Move all line cords and line-powered equipment at least 200 cm away from the monitor. Check for

extension cords running behind or under the bed and equipment in adjacent rooms. If the artifact heart rate indication ceased, the monitor may be used normally.

 Remove all the line cord from the monitor’s power supply. If the artifact heart rate indication

ceased, the monitor may be used normally.

If these measures do not result in cessation of the heart rate artifact, the monitor can’t be safely used in this environment.

Fetal heart rate is measured by placing the ultrasound transducer on the maternal abdomen and by processing the received Doppler echo signal to produce a heart rate and an audio representation of the echo signal.



please cover the patient’s abdomen section which has a possibility of contacting by the cable

6.2 Monitoring sequence overview

Step 1: Preparing the monitor

 Turn the monitor on and verify that the normal monitoring screen appears on the display. Stop

using the monitor if an error occurs.

 Check whether the monitor is powered from the internal battery or AC power. If the monitor is

powered from the internal battery, check the power status from on the display to determine whether the battery has sufficient charge to complete the monitoring session. Use the AC power if the battery is too low.

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 Check the ultrasound transducer to verify proper attachment to the monitor. For monitoring twins,

make sure the second ultrasound transducer is properly connected.

 Adjust channel one speaker volume to the middle level. Adjust channel two speaker volume to

zero if monitoring twins.

 Apply ultrasound gel to the face of the transducer.

Step 2: Acquiring the fetal heart signal

 Determine the location of the fetal heart using palpation or a fetoscope. Place the transducer on

the maternal abdomen and listen to the fetal heart signal. Reposition the transducer for the loudest fetal heart sound.

 Secure the ultrasound transducer with the elastic belt. Make sure that the transducer is still

positioned for the loudest fetal heart signal.

 Verify the monitor is displaying fetal heart rate values and that the heart shape icon on the screen

is blinking at the measured heart rate.

Step 3: Acquiring twin’s heart rate

 Follow step 2 above to acquire the heart rate for the first fetus.  Decrease the channel one speaker volume and increase the channel two speaker volume to hear

the second heart sound.

 Determine the location of the second fetal signal using palpation or fetoscope.  Apply gel to the second ultrasound transducer and place it on the maternal abdomen where the

second fetal signal was located. Reposition the transducer for the loudest fetal heart sound.

 Secure the ultrasound transducer with the elastic belt. Make sure that the transducer is still

positioned for the loudest fetal heart signal.

 Verify the monitor is displaying fetal heart rate values and that the heart shape icon on the screen

is blinking at the measured heart rate.

Step 4: Monitor adjustment

 Readjust the volume settings for the desired loudness.

6.3 Detail procedure

 Explain the procedure to the patient.  Place a probe belt under the patient  Turn the monitor on.

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BT-350 Operation Manual

CAUTION

The probe belt may cause allergy or skin side effects to the patient if it is used so long time.

Doppler Probe

 Connect the ultrasound probe to the “DOP” connector.  Apply a small amount of ultrasound coupling gel to the face of the transducer.  Determine the position of the fetus using Leopold’s maneuvers. The strongest fetal heart tones are

heard through the fetal back.

 Place the transducer face down on the maternal abdomen over the area determined as the fetal

back.

 Secure the transducer comfortable in the place by inserting the transducer button through the

button holes on each end of the belt.



 Adjust the volume as required.

 Press the print button [ ] to activate the printer.

Fig. 6.1 The position of the Doppler probe

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BT-350 Operation Manual

CAUTION

The cable of the UC probe is not intended to contact the patient. To prevent such contact,

with clean gauze or fabric.

7 Uterine contraction (UC)

Uterine contraction is measured externally by placing a pressure sensor (UC sensor) on the maternal abdomen and measure the relative pressure change.



please cover the patient’s abdomen section which has a possibility of contacting by the cable

7.1 Monitoring sequence overview

Step 1: Preparing the monitor

 Turn the monitor on and verify that the normal monitoring screen appears on the display. Stop

using the monitor if an error occurs.

 Check whether the monitor is powered from the internal battery or AC power. If the monitor is

 Check the UC probe to verify proper attachment to the monitor.  Press the UC reference button to adjust the values to the baseline.

Step 2: Acquiring the uterine contraction data

 Place the face (button side) of the UC probe on the fundus on the uterus when contractions are

not occurring. No gel is required.

 Secure the UC probe with the elastic belt. The uterine contraction reading at this point should be

greater than 30 and less than 90 units. If the readings fall outside of this range, the belt may be too tight or too loose. If the belt is overtightened, the contraction peaks may have a flat-top at less than on the UC scale. If the belt is under tightened, the sensor can move and cause unstable readings. Readjust the belt pressure as needed.

7.2 Detail procedure

 Explain the procedure to the patient.  Place a probe belt under the patient  Turn the monitor on.  Connect the UC probe to the “UC” connector.

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BT-350 Operation Manual

Note: After connecting or re-connecting the UC probe to the UC connector, you must wait at least

10 seconds before pressing the UC reference button [ ].

CAUTION

The probe belt may cause allergy or skin side effects to the patient if it is used so long time.

 Press the UC reference button [ ] to set the UC baseline at 10.

 Position the UC probe on the maternal abdomen over the uterine fundus or where there is the

least maternal tissue and the contractions are strongly palpated.

 Secure the UC probe comfortable in the place by inserting the transducer button through the

button holes on each end of the belt.



 Between contractions, press the UC reference button [ ] again. This sets UC baseline to 10.

 Press the print button [ ] to activate the printer.

Fig. 7.1 The position of UC probe

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BT-350 Operation Manual

8 Event marker

8.1 Event marker

The event marker arrow is provided so that the patient can record the time of important events. The patient merely presses the marker button at the time an event occurs. This marker time is recorded in the monitor.

The patient marker icon is an upward pointing arrow [ ]. The monitor will display this arrow in the information frame of the display. A strip chart printout of the patient record will also show this marker.

8.2 Clinical event marker

When an important event, like a fetus movement, occurs, the clinical event marker is used. If necessary, the doctor will press down and hold the mode button [ ] for more than 2 seconds. Then the marker is recorded.

The clinical event marker icon is a downward pointing arrow [ ]. The monitor will display this arrow in the information frame of the display. A strip chart printout of the patient record will also show this marker.

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BT-350 Operation Manual

WARNING

Unplug the monitor from the AC power source and detach all accessories before cleaning. Do not immerse the unit in water or allow liquids to enter the case.

CAUTION

Take extra care when cleaning the display surfaces, which are sensitive to rough handling. Rub them with a soft, dry cloth.

Do not autoclave. Do not gas sterilize.

directly on the transducer.

9 Cleaning and disinfection

BT-350 requires proper care and preventive maintenance. This ensures consistent operation and maintains a high level of performance necessary in monitoring procedures.

9.1 Monitor

Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a damp cloth using mild soap and water or hospital approved nonabrasive disinfectants.



9.2 Probes

To avoid damage to the transducers, clean and disinfect according to the following instructions.

CAUTION



 Do not immerse in liquid. When using solutions, use sterile wipes to avoid pouring fluids

1. Wipe the device with a sterile wipe soaked in enzymatic detergent safe for use with metal

instruments. Wipe the exterior of the device three times. Prepare the detergent according to the manufacturer’s recommendations.

2. Scrub the transducer with enzymatic detergent using a soft bristled brush for five (5) minutes.

3. Wipe the transducer three (3) times with sterile water to remove soap residue.

4. Wipe the transducer with a sterile wipe soaked in Cidex™. Wipe all exterior surfaces of the

transducer three (3) times.

5. Wipe the transducer three (3) times with sterile water to remove Cidex™ residue.

6. Dry the device thoroughly with a sterile soft towel or gauze surgical sponge.

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BT-350 Operation Manual

The water temperature must not exceed 60°C (140°F).

Contacting

component

DOP enclosure

ABS AV20F

Must be cleaned and disinfected prior to use

UC enclosure

ABS AV20F +

Must be cleaned and disinfected prior to use Manufacturer

Active Ingredient

Sterilant

Conditions

High Level Disinfectant Contact

K924434 Cidex™ Activated Dialdehyde Solution

Johnson &

2.4%

10 hrs at 25°C

on ly.

45 min at 25°C

7. Wrap the dry transducer with a fresh sterile soft towel or transparent sterile wrap for storage until

next use.

9.3 Belt

Wash soiled belts with soap and water.

CAUTION



9.4 Contacting components

Material Disinfection

Polyurethane ESTANE S385A-46N

9.5 Description of Cidex

1. Cidex

2. FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and

is FDA-cleared for use in the United States. Therefore we suggest that the disinfection effect using

Cidex

Dental Devices – March 2015 (

information-manufacturers/fda-cleared-sterilants-and-high-level-disinfectants-general-claims-processingreusable-medical-and)

is valid.

Johnson Medical Products

glutaraldehyde

https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices-

Contact

14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test

Conditions

14 days Maximum Reuse Contact conditions based on literature references.

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BT-350 Operation Manual

Dimensions

9.6cm(H) x 32.6 cm(W) x 27.6cm(D)

Weight

Approx. 5.5 kg

Standard

EN 60601-1, EN 60601-1-2, EN 60601-2-37

Classification

Class I, Internal Powered Equipment

Mode of Operation

Continuous operation

Protection against electric

Protection against ingress

Input: AC 100 ~ 240 V, 50/60 Hz

Internal

Battery

14.8V, 2600mAh (Li-ion)

AC-powered

80 VA, maximum

Battery Operating temperature

10°C ~ 40°C (50°F ~ 104°F)

Operating humidity

5 ~ 85%, Non condensing

Storage temperature

-20°C ~ 60°C (-4°F ~ 140°F)

Storage humidity

0 ~ 95%, non-condensing

Altitude

0 ~ 2 000 m(0 ~ 6 561.68 ft)

Pressure

70kPa ~ 106kPa

BPM Range

30 ~ 240 BPM

Accuracy

± 2% of range

Leakage

<10 µA @ 264 VAC applied to the transducer

Isolation

>4 kV RMS, Type BF applied part

UC range

0-100 relative units

Resolution

1 Count

Leakage

<10 µA @ 264 VAC applied to the transducer

Isolation

>4 kV RMS, Type BF applied part

10 Specifications

Physical Characteristics

Safety

shock

of water

Power

External Power adapter

Power Dissipation

Environment

Doppler ultrasound FHR monitoring

Type BF applied part

IPX8(Dop/UC probe)

powered

Output: DC 18V, 2.8A

80 VA, maximum

Uterine Contraction (TOCO) monitoring

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BT-350 Operation Manual

Pack Style

Z-Fold.

Pack Size

150 mm x 90 mm x 15 mm

End-of-Pack

Mark along the paper edge

Open-door, slide-in

Paper Detectors Paper Out

Loading door open

Speed Normal

1, 2 and 3 cm/min ± 1%

High-speed

10 cm/min (only in Trend mode)

Tracking accuracy

± 1% (exclusive of paper accuracy)

Paper

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BT-350 Operation Manual

Acoustic

Output

(mW/cm2)

Global Maximum Value

0.04

17.6

0.396

r. 3

(MPa)

0.063685

(mW)

16.7*

(MHz)

0.985

(cm)

2 2 2

Beam x

-6

(cm) 0.6

0.6

-6

(cm) 1.3

1.3

PD (µsec)

128 128

PRF (Hz)

3472

3470

EBD Az. (cm) 1.1

Ele.(cm) 1.1

Control 1

Default Mode

Control 2

Control 3

Control 4

Control n

Acoustic output information for the transducer assembly

Operating Mode : PW Mode

Associated

Acoustic

Parameter

Operating

Control

Conditions

dimensions

SP TA.3

SPPA .3

- Ultrasonic Power for the transducer assembly =

16.7 mW

- Ultrasonic element diameter = 1.1 cm ( 9 ultrasonic elements are used in the transducer

assembly. )

- Duty Factor(DF) =Pulse Duration x Pulse Repetition Frequency = 128 x 10

-6

x 3,472 = 0.444416

- Area corresponding to entrance beam dimensions = 9(the number of ultrasonic element in the

transducer assembly) x 3.14 x 0.55

- I

@ Transducer Face = Ultrasonic Power / Area Corresponding to entrance beam dimensions

SATA

= 8.54865 cm

= 16.7 / 8.54865 = 1.95352482555725 ≒ 1.95 mW/cm

- I

@ Transducer Face = I

SA PA

@ Transducer Face / DF = 1.95 / 0.444416 ≒ 4.4 mW/cm

SATA

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BT-350 Operation Manual

11 Troubleshooting and maintenance

11.1 Self-test

The monitor performs self-test each time it turns on.

1. Make sure the monitor power is properly connected.

2. Check the printer paper and printer door closed.

3. Connect the probe to the monitor

4. Turn on the monitor.

Check that the monitor successfully powered on and is displaying the main monitoring screen. If an error occurs the monitor will display the error message.

11.2 Ultrasound transducer test

To test the ultrasound transducer:

1. Connect the transducer to the monitor.

2. Turn on the monitor.

3. Adjust the speaker volume to an audible level.

4. Hold the transducer on one hand and tap on the transducer face with the other hand. The tapping

sound should be heard from the speaker.

5. The transducer is operating properly if you can hear the sound from the speaker. If no sound is

heard, please stop using the transducer and call for the service.

11.3 UC (TOCO) probe test

To test the UC (TOCO) probe:

1. Connect the probe to the monitor.

2. Turn on the monitor.

3. Gently apply pressure to the button centered on the face of the probe.

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BT-350 Operation Manual

4. The change of pressure should be displayed on the screen if the probe operating properly. If

there are no changes, please stop using the probe and call for the service.

11.4 Battery

The capacity of the battery is gradually decreased over time and usage. Consequently, the operating time with the battery can be reduced. If the operation time is not long enough, please contact the service center and change the battery.

11.5 Maintenance

BT-350 monitor and accessories do not require periodic calibration or adjustment. The recommended interval for performing dielectric strength and leakage current testing is once per year.

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BT-350 Operation Manual

WARNING

Use of accessories, transducers and cables other than those specified or provided by

NOTE: The EMISSIONS characteristics of this equipment make

12 Manufacturer’s declaration on EMC

BT-350 needs special precautions regarding EMC (Electromagnetic compatibility) and needs to be used according to the EMC information provided in this user manual. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect the BT-350 and should be kept at least 1 m away from the equipment.



the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

 Medical electrical equipment needs special precautions regarding EMC and needs to

 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

12.1 Electromagnetic emissions

The BT-350 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-350 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

Class A

The BT-350 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

it suitable for use in industrial areas and hospitals (CISPR 11 class A). The BT-350 is suitable for use in all establishments other than domestic, and may be used in domestic establishments and

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BT-350 Operation Manual

those directly connected to the public low-voltage power

The BT-350 is intended for use in an electromagnetic environment in which radiated RF disturbances

50 can help prevent electromagnetic

by maintaining a minimum distance between portable and mobile RF communications

Separation distance according to frequency of transmitter

0.01

0.1

100

For transmitters rated at a maximum output power not listed above, the recommended separation

maximum output power rating of the transmitter in watts (W) according

Harmonic emissions IEC 61000-3-2

Class A

supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Warning: This BT-350 is intended for use by healthcare

professionals only. This equipment/system may cause radio

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the BT-350 or shielding the location.

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

are controlled. The customer or the user of the BT-3 interference equipment (transmitters) and the BT-350 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum

[m]

output power of

transmitter

[W]

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.12 0.12 0.23

0.38 0.38 0.73

1.2 1.2 2.3

3.8 3.8 7.3

12 12 23

distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the to the transmitter manufacturer.

NOTE 1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

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BT-350 Operation Manual

IEC 60601

Electromagnetic environment -

Electrostatic

±6 kV Contact

Floors should be wood, concrete or

Electrical fast

±2 kV for power

Mains power quality should be that Surge

±1 kV line(s) to line(s)

Mains power quality should be that

Voltage dips, short

< 5 % Uт

Mains power quality should be that

Power frequency (50

3 A/m

Power frequency magnetic fields

12.3 Electromagnetic immunity

The BT-350 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-350 should assure that it is used in such an environment.

Immunity test

discharge (ESD)

IEC 61000-4-2

transient/burst

IEC 61000-4-4

IEC 61000-4-5

interruptions and voltage variations on power supply input lines

IEC 61000-4-11

Test level

±8 kV air

supply lines ±1 kV for input/output lines

±2 kV line(s) to earth

(> 95 % dip in Uт) for 0.5cycle

40 % Uт (60 % dip in Uт ) for 5 cycle

70 % Uт (30 % dip in Uт) for 25 cycle

<5 % Uт (> 95 % dip in Uт ) for 5 s

Compliance level

±8 kV air

supply lines ±1 kV for input/output lines

±2 kV line(s) to earth

(> 95 % dip in Uт) for 0.5cycle

40 % Uт (60 % dip in Uт ) for 5 cycle

70 % Uт (30 % dip in Uт) for 25 cycle

<5 % Uт (> 95 % dip in Uт ) for 5 s

guidance

ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

of a typical commercial or hospital environment.

of a typical commercial or hospital environment. If the user of the BT350 requires continued operation during power mains interruptions, it is recommended that the BT-350 image intensifier be powered from an uninterruptible power supply.

Hz and 60 Hz) magnetic field

IEC 61000-4-8

NOTE Uт is the a.c. mains voltage prior to application of the test level.

should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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BT-350 Operation Manual

Compliance

level

Portable mobile RF communications

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF

observed to verify normal operation. If abnormal performance is observed, additional

Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.

The BT-350 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-350 should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 Vrms

3 V/m

Electromagnetic environment - guidance

equipment should be used no closer to any part of the BT-350, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

should be less than the compliance level in

each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol :

NOTE 1) At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be

transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BT-350 is used exceeds the applicable RF compliance level above, the BT-350 should be measures may be necessary, such as re-orienting or relocating the BT-350.

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BT-350 Operation Manual

Product Name

Fetal Monitor

Model Name

BT-350

Serial No.

Warranty Period

2 Years (Probe excluded)

Date of Purchase

Hospital:

Sales Agency

Manufacture

Bistos Co., Ltd.

Product Warranty

Address:

Customer

※ Thank you for purchasing BT-350. ※ This product is manufactured and passed through strict quality control and inspection. ※ Compensation standard concerning the repair, replacement, refund of the product complies with

“Framework Act on Consumers” noticed by Fair Trade Commission of the Republic of Korea.

Name:

Telephone:

Service Telephone and Fax. Numbers

Telephone: +82 31 750 0340

Fax: +82 31 750 0344

FL., A Bldg., Woolim Lions Valley 5-cha, 302,

Galmachi-ro, Jungwon-gu, Seongnam-si,

Telephone: + (32) 2. 732.59.54

Bistos Co., Ltd.

Gyeonggi-do, Korea

www.bistos.co.kr

bistos@bistos.co.kr

Obelis s.a

Bd. Général Wahis 53

1030 Brussels, BELGIUM

Fax.: + (32) 2.732.60.03