Bistos BT-220 User manual

BT-220
Operation Manual
.
BT-220
Keep this manual for future reference
P/N: 220-ENG-OPM-EUR-R03

BT-220 Operation Manual 1
P/N : 220-ENG-OPM-EUR-R03
Bistos Co.,Ltd
2018.06
Proprietary Material
Information and descriptions contained in this manual are the property of Bistos Corporation and may
not be copied, reproduced, disseminated, or distributed without express written permission from
Bistos Corporation.
Information furnished by Bistos Corporation is believed to be accurate and reliable. However, no
responsibility is assumed by Bistos for its use, or any infringements of patents or other rights of third
parties that may result from its use. No license is granted by implication or otherwise under any patent
or patent rights of Bistos
Revision 03
June, 2018
Copyright © Bistos Corporation 2018. All rights reserved.
7th Fl., ABldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro
Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea
Telephone: [phone]
Fax: [phone]
Printed in Korea

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P/N : 220-ENG-OPM-EUR-R03
Bistos Co.,Ltd
2018.06
Table of Contents
1. SAFETY .................................................................................................3
1.1 Instructions for the Safe Operation and Use of the BT-220 Doppler .......................................3
1.2 Warnings....................................................................................................................................3
1.3 Cautions.....................................................................................................................................4
1.4 Definitions of Symbols..............................................................................................................5
2. INTROCUTION ........................................................................................6
2.1 Product Overview......................................................................................................................6
2.2 Intended Use..............................................................................................................................6
2.3 Product Features ........................................................................................................................6
2.4 Product Configuration................................................................................................................6
2.5 Exterior Component Designation ..............................................................................................7
3. OPERATION............................................................................................9
3.1 Controls and Indicators..............................................................................................................9
3.1.1 Button and Description.........................................................................................................9
3.1.2 Symbols and Description......................................................................................................9
3.1.3 Mode and Description......................................................................................................... 10
3.1.4 Battery Charging.................................................................................................................10
3.1.5 Automatic Shutdown ..........................................................................................................10
3.1.6 Use of Probe ....................................................................................................................... 10
3.2 Operation of BT-220................................................................................................................11
3.2.1 LCD Display.......................................................................................................................11
3.2.2 FHR Mode..........................................................................................................................12
3.2.3 BMI calculation Mode........................................................................................................ 13
3.2.4 BIATREND .......................................................................................................................15
3.2.5 Unit Setting......................................................................................................................... 16
4. MAINTENANCE & CLEANING..............................................................17
4.1 Main Body & Probe.................................................................................................................17
4.2 Cable........................................................................................................................................17
4.3 Battery Disposal and Handling................................................................................................17
4.4 Request a service for General Problems..................................................................................17
5. SPECIFICATIONS .................................................................................18
6. DECLARATION ON EMC......................................................................19
6.1 Electromagnetic emmission .......................................................................................19
6.2 Recommended separation distances between portable and mobile RF
communications equipment and the BT-220 .............................................................19
6.3 Electromagnetic immunity..........................................................................................20
6.4 Immunity and Compliance Level................................................................................22

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2018.06
Section 1
Safety
1.1 Instructions for the Safe Operation and Use of the
BT-220 Doppler
Examine the Doppler and any accessories periodically to ensure that the cable and batteries
do not have visible evidence of damage that may affect patient safety or performance. Do
not use the Doppler if there is any visible sign of damage.
Do not attempt to service the BT-220 Doppler. Only qualified service personnel by Bistos
Co., Ltd. should attempt any needed internal servicing.
The BT-220 is not specified or intended for operation during the use of defibrillators or
during defibrillator discharge.
The BT-220 is not specified or intended for operation in the presence of electrosurgical
equipment.
The BT-220 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
Operation Manual.
Do not operate the BT-220 Doppler if it fails to pass the power on procedure.
WARNING A hazard of serious injury or death
CAUTION A hazard of minor injury or damage to the system.
1.2 Warnings
WARNING

EXPLOSION HAZARD - Do not use the BT-220 in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occu r.
SHOCK HAZARD - BT-220 does not have protection against the burn injury caused
by RF surgical equipment. Do not use this product along with RF surgical
equipment.

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1.3 Cautions
CAUTION

The relevant law restricts this device to sale by or on the order of a physician.
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 ultrasound transmission gel and other substances.
General Precaution on Environment
Do not keep or operate the equipment under the environment listed below.
Avoid placing in an area
exposed to moisture.
Do not touch the
equipment with wet
hand.
Avoid exposure to
direct sunlight
Avoid placing in an area
where there is a high
variation of
temperature.
Operating temperature
ranges from 10°C to
40°C. Operating
humidity ranges from
30% to 85%.
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 there is an
excessive shock or
vibration.
Avoid placing in an area
where chemicals are
stored or where there is
in danger of gas
leakage.
Avoid dust and
especially metal
material into the
equipment.
Do not disjoint or
disassemble the
equipment.
BISTOS Co., Ltd. does
not take responsibility of
it.
Power off when the
equipment is not fully
installed.
Otherwise, the
equipment could be
damaged.

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1.4 Definitions of Symbols
Symbol
Description
Power On/Off Button
This symbol identifies a caution. Ensure you understand the
function of this control before using it. Control function is
described in the operation manual.
Type BF Equipment
IPX7 IPX7 Waterproof
When disposing of some components, do not dispose as general
wastes.
Adhere to all applicable laws regarding recycling.
CAUTION

Federal law restricts this device to sale by or on the order of a physician.

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Section 2
Introduction
2.1 Product Overview
BT-220 is a pocket-size fetal Doppler that measures the fetal heat rate and outputs the fetal heart
sound through built-in speaker. By measuring fetal heart rate (FHR), you are able to predict fetal
well-being. BT-220 irradiates ultrasound wave to the abdomen of a pregnant woman to detect the
Doppler frequency signal and analyze, and displays the heart rate on screen. The device also
provides the heart sound from the heart of fetus.
2.2 Intended Use
The BT-220 is a potable fetal Doppler that measures the fetal heart rate and outputs the fetal heart
sound through a built-in speaker. Measuring the fetal heart rate (FHR) gives an indication of fetal
well-being. This data is intended to aid in assessing the well being of the fetus (Non-Stress Test). This
device is for use only by trained medical personnel located in hospitals, clinics, doctor’s offices.
2.3 Product Features
The BT-220 is a microprocessor-based fetal Doppler, which display and output the fetal heart rate and
sound for antepartum testing.
①Compact (Pocket size) and light
②Easy to use
③Low Power consumption
④Long time use
⑤High quality sound
2.4 Product Configuration
BT-220 consists of the followings. Unpack the package and check out the following items. Also be
sure to check any damage of main body, probe and accessories.
①BT-220 main body and probe
②1.5V Battery (2EA)
③Ultrasound transmission gel (1EA)
④Quick guide (1EA)

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2.5 Exterior Component Designation
◎Front View, Top View & Right View
◊
BT-220L
①Custom Mono LCD
②Power and Mode Button, Speaker test and Up/Down Button
③Charging Indicator LED
④Built-in speaker
⑤Ear Phone Jack
◊
BT-220C
①TFT Color LCD
②Power and Mode Button, Speaker test and Up/Down Button
③Charging Indicator LED
④Built-in speaker
⑤Electrode Plate
⑥Ear Phone Jack

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◎Rear View, Bottom View & Left View
①Product Label
②Battery Compartment
③Probe Groove Joint
④Probe Connection and Charging Jack
◎Probe
①Sensor
②Probe Groove Joint
③Probe Connector

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Section 3
Operation
3.1 Controls and Indicators
3.1.1 Button and Description
◊
BT-220L
Button
Description
Speaker test On/Off
Volume Down
Volume Up
Power On/Off
◊
BT-220C
Button
Description
Mode change or menu select
Volume Down, Speaker teste on and data value decrease
Volume Up, Speaker test off and data value increase
Power On/Off
3.1.2 Symbols and Description
◊
BT-220C
Symbol
Description
Battery indicator
Doppler volume indicator
Doppler volume mute indicator
Low battery indicator
Battery charge indicator

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3.1.3 Mode and Description
◊
BT-220C
Symbol
Description
FHR Number
This mode displays fetal heart rate and
heart rhythm with heart sound
FHR Graph
This mode displays fetal heart rate, heart
rhythm and change of heart rate with
heart sound
BMI calculation This mode displays the BMI
BMI trend This mode displays saved data of BMI
Unit setting
This mode set the unit of height, weight,
and start mode.
3.1.4 Battery Charging
If the voltage level of battery is lower than the required level, the low battery indicator will appear on
middle of screen. In this case, the unit will not functional correctly and the batteries should be
replaced. Please replace with AA type 1.5V battery.
If you want to use the rechargeable battery, please use AA type, 1.2V, Ni-MH battery. To charge the
battery, connect your computer's USB to probe connection and charging jack (see the bottom view on
page 11 of this manual).
Indicator
charging
Completing the charging.
Blue LED is OFF.
Blue LED is ON.
Charging time
General(2000mAh)
Under approx. 400 minutes
* During the charging the device does not operating.
3.1.5 Automatic Shutdown
If the device is not used for 1 minute, it stops the heart sound with "beep" sound, and shutdown in 3
minutes with another "beep" sound.
If the battery voltage is dropped or the device being charged during the use, the device will shut down
automatically.
3.1.6 Use of Probe
Apply a moderate amount of ultrasound gel to the face of the end of the probe.
Place the probe directly against the measuring position.
Search for the fetal heart by slowly moving the probe around until the fetal heart sounds are heard.

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Search for the position which can get the clearest sound.
3.2 Operation of BT-220
3.2.1 LCD Display
◊
BT-220L
<Measurement>
When the input signal is good and stable, FHR will appear on the screen and the solid heart rhythm
indicator will flash as shown in Figure.
When the input signal is not stable, only the outline of heart rhythm indicator will flash.
If the voltage level of battery is lower than the required level, the battery low message ”bat Lo” will
appear. In this case, the unit will not functional correctly and the batteries should be replaced.
<Volume Level>
Press the volume up/down button to adjust the volume level (1~4).
Ultrasound transducer

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◊
BT-220C
BT-220C has totally four modes. You can select the mode by pressing button for a short time.
FHR Number mode
FHR Graph mode
BMI mode
BMI trend mode
3.2.2 FHR(Fetal Heart Rate) Mode
When the input signal is good and stable, FHR will appear on the screen and the solid heart rhythm
indicator will flash as shown in Figure.
1) Mode change (FHR Number →FHR Graph): Press the mode button [ ].
①
Heart rhythm indicator
②
Heart rate (HR) value
③
Average HR value
④
Operating time of FHR
⑤
Function of button
⑥
Graph of HR
When the input signal is not stable, only the outline of heart rhythm indicator will flash.
‘AVG’ represents the average value of the stable heart rate and ‘TIME’ represents listening time of
heat beat.
The bold lines in graph region represent the stable heart rate.

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2) To control the volume: Press the button to adjust volume (1 ~ 4 levels). The current
volume setting is displayed be icon on the upper right corner of screen.
3) Speaker test operation (FHR graph AST): Press the button shortly.
<AST Operation>
Use the button for generating sound. The sound is generated only at speaker. AST1 has 75 Hz
and AST2 has 100 Hz frequency.
3.2.3 BMI(Body mass index) Mode
BT-220 displays BMI(Body Mass Index) using the weight and height.
1) Mode Change (FHR mode →BMI mode): Press the button for a short time.
BMI mode Delete data

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①
Function of button
②
Last measured data
③
Entered information
④
Body composition graph
⑤
Pop-up window for deleting data
2) Information Setting: Press the button to enter the start menu.
Item Select: Press the button to select item (Sex, Age, HT, WT)
Change Value : Use the button to change the value.
(Information of age, height, and weight is not cleared)
①
Function of button
②
Start/Cancel
③
Entered information
If all information has been modified or changed press mode button to select [START/CANCEL]
menu.
3) Start Measurement: when the cursor is on [START CANCEL], press the button to start
measurement or press the button to cancel (return to BMI mode).

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<Ready> <Processing>
After pressing start, touch the metal electrode on the left side on main body with both thumbs. Then
measurement begins automatically. If the contact area is small, the measurement may be inaccurate
Information of setting age, height, weight will be saved automatically.
Automatically measured HR, BMI, FAT is stored (up to 10).
4) Delete Data : Press the button to delete data. Use the button to select the menu and
press button to select the operation.
3.2.4 BMI TREND
①
Function of button
②
Measured data
③
Last entered information
④
Graph of stored data
1) Mode Change: Press the button shortly to change the mode to FHR numeric mode
2) Stored Data Review: Press the button to see the stored data.

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3.2.5 UNIT Setting
①
Unit set value
②
Function of buttons
1) To enter unit setting menu, press down the button about 2 seconds.
2) Item select: Press the button shortly
3) Value Change: Press the button.
4) The following items can be changed:
DISP: Default display when power ON. Dop(N): Doppler Normal, Dop(G): Doppler Graph,
Bmi(M): Bmi measurement, Bmi(T): Bmi trend.
HT: The unit of height for BMI. cm/ft
WT: The unit of weight for BMI. kg/lb
5) To exit unit setting and return to the current operating mode, press down the button about 2
seconds.

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Section 4
Maintenance & Cleaning
This chapter contains instructions for the care and cleaning of the BT-220 unit and its accessories.
The BT-220 requires proper care and preventive maintenance. If you use the material that is not
approved, it may cause any damage to the product. In this case, the product will not be guaranteed
even within the warranty period.
4.1 Main Body & Probe
To keep the device clean, apply alcohol on a soft cloth and scrub the body and the probe once a month.
Do not use lacquer, thinner, ethylene, or the oxidizing substance. Keep the probes from dust or stain.
Do not soak the main body and the probe into any liquid or detergent. Keep the main and the probe
away from any liquid.
CAUTION

Check the main body and the probe thoroughly after cleaning.
4.2 Cable
Wipe the cable with a soaked cloth that is wet with warm water (40℃/ 104℉), and with the clinical
alcohol once a week.
CAUTION

Do not autoclave. Do not gas sterilize.
4.3 Battery Disposal and Handling
NOTE

1.5V X 2(AA type) batteries are used for the system power. Do not use the
other type battery. It could be the cause of breakdown.
4.4 Request a service for general problems
If the main body or accessories are damaged by excessive mechanical forces, narrow cracks or
separation of ultrasonic sensor can be happened. These can be checked through visible or auditory
decision. These can cause malfunction some times. But these do not cause unacceptable risks. If the
BT-220 does not work properly, please contact us and change the corresponding parts. Note that the
replacement costs can be occurred.

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Section 5
Specifications
BT-220 fetal Doppler is complies with IEC 60601-1 and IEC 60601-1-2. And the ultrasound
Doppler system complies with IEC 60601-2-37.
General
Ultrasound Frequency 2MHz, 3Mhz
Intensity
Less than 10mW/cm2
Heart rate counting range
50 ~ 240 bpm(BT-220L)/
30 ~ 240 bpm(BT-220C)
FHR accuracy
±2% of range
Sensitivity
10 ~ 12 weeks onward
PC interface
Sound card (using by BCM200 s/w)
Physical Characteristics
Main body (L)132㎜×(H)66㎜×(D)27.6㎜
Probe
(L)162
㎜
×(H)29.3
㎜
×(D)27.8
㎜
Weight (Main body and probe)
190 g(BT-220L) / 200 g(BT-220C)
Safety classification
Protection against electric shock
Internal powered equipment
Protection level against electric shock Type BF
Mode of operation
Continuous operation
Protection against ingress of water
Probe: IPX7
Main body: IPX0
Power
Battery
AA type 1.5V X 2
About 240 minutes (continuous use)
Environment
Operating Temperature 10℃(50℉) to 40℃(104℉)
Operating Humidity 30% ~ 85% non-condensing
Operating Atmospheric Pressure
79.051
㎪
~ 101.325
㎪
Storage Temperature
Main body: IPX0
Storage Humidity
-10
℃
(14
℉
) to 60
℃
(131
℉
)
Storage Atmospheric Pressure
79.051
㎪
~ 101.325
㎪

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Section 6
Declaration on EMC
6.1 Electromagnetic emissions
The BT-220 is intended for use in the electromagnetic environment specified below.
The customer or the user of BT-220 should assure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11 Group 1
The BT-220 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.
RF emissions
CISPR 11
Class B
The BT-220 is suitable for use in all
establishments by using a battery.
Harmonic emission
IEC61000-3-2
Not applicable
Voltage fulctuations
/flicker emissions
IEC61000-3-3
Not applicable
6.2 Recommended separation distances between portable and mobile RF
communications equipment and the BT-220
The BT-220 is intended for use in the electromagnetic environment in which radiated
RF disturbances are controlled.
The customer or the user of the BT-220 can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitter) and the BT-220 as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum output
power of transmitter [W]
Separation distance according to frequency of
transmitter[M]
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2.5 GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23