Bistos BT-200 User manual

BT-200(Hi-bebe)
Fetal Doppler
Operation manual
.
BT-200
Keep this manual for future reference
P/N: 200-ENG-OPM-EUR-R06

BT-200 Operation Manual
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P/N: 200-ENG-OPM-EUR-R06
Bistos Co.,Ltd
2018,03
Proprietary Material
Information and descriptions contained in this manual are the property of Bistos Co., Ltd.
and may not be copied, reproduced, disseminated, or distributed without express
written permission from Bistos Co., Ltd.
Information furnished by Bistos Co., Ltd. is believed to be accurate and reliable. However,
no responsibility is assumed by Bistos Co., Ltd. for its use, or any infringements of
patents or 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 Co., Ltd.
Revision 06
Mar,2018
Copyright © Bistos Co., Ltd. 2017. All rights reserved.
7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro
Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea
Telephone: [phone]
Fax: [phone]
Printed in Korea

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Table of Contents
1. SAFETY ...........................................................................................3
1.1 Instructions for the Safe Operation and Use of the BT-200 ..........................................3
1.2 Warnings.........................................................................................................................4
1.3 Cautions..........................................................................................................................4
1.4 Definitions of Symbols ...................................................................................................
6
2. INTROCUTION ..................................................................................7
2.1 Intended use ....................................................................................................................7
2.2 Indications for Use..........................................................................................................7
2.3 Product Configuration.....................................................................................................7
2.4 Exterior Component Designation....................................................................................8
3. OPERATION......................................................................................9
3.1 Operation requirements...................................................................................................9
3.2 How to use? ....................................................................................................................9
3.3 Basic clinical information...............................................................................................9
3.4 Maintenance and cleaning...............................................................................................9
4. GENERAL INFORMATION AND SPECIFICATIONS ......................10
5. DECLARATION ON EMC................................................................11
5.1 Electromagnetic emmission..........................................................................................11
5.2 Recommended separation distances between portable and mobile RF communications
equipment and the BT-200...........................................................................................11
5.3 Electromagnetic immunity............................................................................................12
PRODUCT GUARANTEE ......................................................................14

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Section 1 Safety
1.1 Instructions for the Safe Operation and Use of the BT-200
•
Examine the device and any accessories periodically to ensure that there is no visible
evidence of damage that may affect patient safety or performance. The
recommended inspection interval is once per week or less. Do not use the device if
there is any visible sign of damage.
•Do not attempt to service the HI•bebe Doppler BT-200. Only qualified service
personnel by Bistos Co., Ltd. should attempt any needed service.
•HI•bebe Doppler BT-200 is not specified or intended for operation during the use of
defibrillators or during defibrillator discharge.
•HI•bebe Doppler BT-200 is not specified or intended for operation in the presence of
electrosurgical equipment.
•HI•bebe Doppler BT-200 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 HI•bebe Doppler BT-200 if it fails to pass the power on
procedure.
CAUTION 
Be informed that it may cause no harm in life but lead to injury against
the “Caution” sign.
NOTE 
Be informed that it may cause a potential hazardous situation which, if
not avoided, may result in minor or moderate injury.

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1.2 Warnings
WARNING 
EXPLOSION HAZARD - Do not use the HI•bebe Doppler BT-200 in a
flammable atmosphere where concentrations of flammable anesthetics
or other materials may occur.
SHOCK HAZARD - HI•bebe Doppler BT-200 doesn't have protection
against the burn injury caused by RF Surgical equipment. Do NOT use
this product along with RF Surgical equipment.
Use of cable or accessories which do not supplied or specified by
manufacturer can cause degrade of EMC characteristics or negative
effect on HI•bebe Doppler BT-200.
HI•bebe Doppler BT-200 should not be used any active implantable or
body- worn medical device, including pacemakers, ICDs,
neurostimulators, and insulin pumps simultaneously.
No modification of this device is allowed. Do not modify this device
without authorization of the manufacturer. If this device is modified,
appropriate inspection and test shall be conducted to ensure continued
safe use of device.
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 transducer gel and other
substances.
HI•bebe Doppler BT-200 classified as internally powered equipment
according to IEC 60601-1 Medical Electrical Equipment - Part 1: General
requirements for basic Safety and essential performance
HI•bebe Doppler BT-200 is classified as Class B according to IEC60601-
1-2 Medical Electrical Equipment - Part 1-2 : General requirements for
basic Safety and essential performance – Collateral standard:
Electromagnetic compatibility

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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
This symbol identifies a safety note. Ensure you understand the
function of this control before using it. Control function is described in
the operation manual.
Type BF Equipment
IPX2, IPX7 Degree of Waterproof
This symbol indicates the manufacturer.
This symbol indicates the serial number of the device.
This symbol indicates the authorized representative in the European
Community of manufacturer.
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 compliance with the essential requirements
and provisions of the Medical Device Directive 93/42/EEC as amended
by 2007/47/EEC.
When disposing of some
components, do not dispose as general
wastes.
Adhere to all applicable laws regarding recycling.
T
his symbol means an item is known to pose hazards in all MRI
environments.
※According to IEC 60601-1-6 General requirements for basic safety and essential performance
– Collateral Standard: Usability, the definition and using these symbols is adjusted.
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 Intended use
HI•bebe Doppler BT-200 is a pocket-size fetal Doppler that measures the fetal heat rate and
outputs the fetal heart sound through built-in speaker. Measuring the FHR gives an indication of
fetal well-being.
2.2 Indications for Use
The HI•bebe Doppler BT-200 is a pocket sized ultrasonic fetal monitor that measures heart rate,
which is displayed on an LCD display, and outputs fetal heart sounds through a built in speaker.
The fetal heart rate is measured using Doppler ultrasound.
2.3 Product Configuration
HI•bebe Doppler BT-200 consists of the following. Unpack the package and check out the
following items. Also be sure to check any damage of main body, probe and accessories.
①BT-200 main body and probe(Refer to the below table)
②1.5V Battery(2EA)
③Ultrasound transmission gel (1EA)
④User’s manual (1EA)
⑤Carrying case(pouch, 1EA)
BT-200 series comparison table
Series 200S 200L 200T 200C
Display
LCD type None Mono LCD Mono LCD Color LCD
Heart rate
range(bpm)
Not displayed 50~240 ±2% 50~240 ±2% 50~240 ±2%
Ultrasound frequency
(MHz)
2 2 3 2
probe
Water proof
IPX7 IPX7 IPX7 IPX7
Probe
type
Non-
detachable
Non-
detachable
Non-
detachable
Non-
detachable

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2.4 Exterior Component Designation
◎
Front View & Top View
①Power and Volume Switch
②Ear phone jack
③Ring for necklace
④Probe holder
⑤LCD display
◎
Rear View
①Battery compartment
②Label
③Ring for necklace
④Power and Volume Switch
◎
Probe
①Transducer
②Groove joint

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Section 3 Operation
3.1 Operation requirements
•The ambient temperature and humidity of the HI • bebe BT-200 should to be
10℃∼40℃and 30% ~ 85％.
•Handle with care.
•Avoid dust or flammable materials.
•When changing the batteries, make sure the batteries are inserted correctly.
•When detaching the probe from the main body, slide the probe upwards to prevent
damage.
3.2 How to use?
•Turn the power and volume switch counterclockwise to turn the device on and adjust
the volume level.
•Apply a liberal amount of ultrasound gel to the face of transducer (end of the probe).
•Place the transducer directly against the abdomen, just above the point where the
pelvic bones meet.
•Search for the fetal heart by slowly moving the probe around until the fetal heart
sounds are heard.
•Search for the position which can get the clearest heart sound.
3.2.1 HI • bebe BT-200 LCD
•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, the outline 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.
3.2.2 HI • bebe BT-200 Sound
•FHR measuring method : Calculate the FHR for 1 minute.
3.3 Basic clinical information
The fetal heart rate range is normally between 120 – 160 BPM (beats per minute).
When the fetal heart rate remains outside of this normal range for an extended period,
please seek advice from your obstetrician.
3.4 Maintenance and cleaning
To keep clean, wipe the body and probe regularly with an alcohol based clinical wipe.
Do not use the following agents: lacquer, thinner, ethylene or an oxidizing agent as
these could damage the device.
Do not under any circumstances immerse the device in cleaning fluid.
Power
on LED
Heart
Rhythm
Battery
Low
FHR
Battery
Heart
Rhythm
FHR

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Section 4 General information and specifications
•Turn the power off after use. If you do not turn the power switch off, 1 minute later, the
sound will be muted automatically. In this case, a single “beep” sound will be heard. 3
minutes later, the system will go to sleep mode. In this case two “beep” sounds will be
heard. The display will be turned off. In this mode power very little power is consumed.
If you want to wake up the device from sleep mode, turn the power off and then 1
second later turn the switch on by turning the switch counterclockwise.
•1.5Vⅹ2(AA Type) Batteries are used for the system power. Do not use any other type of
battery. Use of the wrong battery type may damage the equipment.
•Do not open the device cover or disassemble the device. Refer servicing to qualified
personnel of Bistos Co., Ltd.
General
Ultrasound center frequency
Refer to the comparison table on page 7
Intensity <10 mW/cm
2
Heart rate range
50~240 bpm
FHR accuracy ±2% of range
Sensitivity 10 ~ 12 weeks onward
Physical characteristics
Main body
(L)75
㎜
×(H)128
㎜
×(D)26
㎜
Probe
200S/C/L/T: (L)27.8
㎜
X (H)160.25
㎜
X (D)27.8
㎜
200V : (L)25 ㎜X (H) 131/139 ㎜X (D) 25 ㎜
Weight(Main body with probe) 190 g
Electrical safety
Compliance with IEC 60601-1, IEC 60601-1-2
Ultrasound Doppler system according to IEC 60601-2-37
Internally powered equipment
Type BF applied parts
Probe waterproof Level IPX7 ,IPX2
Power
Battery
1.5V X 2 (AA type)
About 280 minutes for continuously use
Environmental conditions
Operation
Storage
Temperature
10
℃
(50
℉
) ~ 40
℃
(104
℉
)
-20
℃
(14
℉
) ~ 60
℃
(131
℉
)
Relative Humidity 30% ~ 85% non-condensing
Atmospheric pressure 79.051 ㎪~ 101.325 ㎪

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Section 5 Declaration on EMC
5.1 Electromagnetic emissions
The BT-200 is intended for use in the electromagnetic environment specified below. The
customer or the user of BT-200 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11 Group 1
The BT-200 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-200 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
5.2 Recommended separation distances between portable and mobile RF
communications equipment and the BT-200
The BT-200 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the BT-200
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the BT-200 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 80MHz
= 1,2√
80 MHz to
800 MHz
= 1,2√
800 MHz to
2.5 GHz
= 2,3√
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
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according 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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5.3 Electromagnetic immunity
The BT-200 is intended for use in the electromagnetic environment specified below. The
customer or the user of the BT-200 should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic
environment-guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV Contact
±8 kV air
±6 kV Contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5 % Uт
(> 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
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the BT-200 image intensifier
requires continued
operation during power
mains interruptions, it is
recommended that the BT-
200 image intensifier be
powered from a battery.
Power frequency
(50 Hz and 60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE: UTis the a.c. mains voltage prior to application of the test level.

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The
BT-200 is intended for use in the electromagnetic environment specifiedbelow.
The
customer or the user of the BT-200 should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment-
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V
rms
150 kHz ~ 80 MHz
3 V/m
80
MHz ~ 2.5 MHz
3 V/m
3 V/m
Portable mobile RF communications
equipment should be used no closer
to any part of the BT-200, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation distance
= 1,2√
= 1,2√80
MHz ~ 800 MHz
= 2,3√800
MHz ~ 2.5 GHz
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 deter-mined by an
electromagnetic site survey, a should
be less than the compliance level in
each frequency range.b
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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the BT-200 is used
exceeds the applicable RF compliance level above, the BT-200 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the BT-200.
b
Over the frequency range 150 kHz to 80 MHz , field strengths should be less than 3 V/m.

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Product Guarantee
Product Name
Ultrasound Doppler System
Model Name
HI•bebe Doppler BT-200
Approval No.
Approval Date
Serial No.
Warranty Period
1 Years (Probe excluded)
Date of Purchase
Customer
Hospital:
Address:
Contact Name:
Telephone:
Sales Agency
Manufacture Bistos Co., Ltd.
※Thank you for purchasing HI•bebe Doppler BT-200.
※This product is manufactured and passed through strict quality control and
inspection.
※Compensation standard concerning repair, replacement, refund of the product
complies with “Framework Act on Consumers” noticed by Fair Trade Commission of
Republic of Korea

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Service Telephone and Fax. Numbers
Telephone: [phone]
Fax: [phone]
Bistos Co., Ltd.
7th FL., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro,
Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea
www.bistos.co.kr
[e-mail]
Obelis s.a
Bd. Général Wahis 53
1030 Brussels, BELGIUM
Telephone: + (32) 2. 732.59.54
Fax.: + (32) 2.732.60.03