BT-220
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 fo r its use, o r any infringeme nts of patents or other rights of third
parties that may result from its use. No license is granted by implication or other wise unde r any patent
or patent rights of Bistos
Revision 03
June, 2018
Copyright © Bistos Corporation 2018. All rights reserved.
7
th
Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro
Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea
Telephone: +82 31 750 0340
Fax: +82 31 750 0344
Printed in Korea
BT-220 Operation Manual 2
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 U s e .............................................................................................................................. 6
2.3 Product Features ........................................................................................................................ 6
2.4 Product Configuration ................................................................................................................ 6
2.5 Exterior Component Designatio n .............................................................................................. 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 BIA TREND ....................................................................................................................... 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. DECLARATIO N ON EMC ...................................................................... 19
6.1 Electromagnetic emmission ....................................................................................... 19
6.2 Recommended separation distances between portable and mobile RF
communications equipm ent and the BT-220 ............................................................. 19
6.3 Electromagnetic immunity .......................................................................................... 20
6.4 Immunity and Compliance Level ................................................................................ 22
BT-220 Operation Manual 3
P/N : 220-ENG-OPM-EUR-R03
Bistos Co.,Ltd
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 o r 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 o ther t ype 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.
BT-220 Operation Manual 4
P/N : 220-ENG-OPM-EUR-R03
Bistos Co.,Ltd
2018.06
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 p lacing 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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P/N : 220-ENG-OPM-EUR-R03
Bistos Co.,Ltd
2018.06
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 usi ng it. Control function is
described in the operation manual.
Type BF Equipment
IPX7
IPX7 W a terpr oof
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.
BT-220 Operation Manual 6
P/N : 220-ENG-OPM-EUR-R03
Bistos Co.,Ltd
2018.06
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 throug h 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. T his da ta is inte nded to a id in asse ssin g t he we ll b ei ng o f t he fe tu s ( N on -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.
① Compact (Pocket size) and light
② Easy to use
③ Low Power consumption
④ Long time use
⑤ High quality sound
2.4 Product Configuration
BT-220 consists of the followings. Unpack the package and c heck out the following items. Also be
sure to check any damage of main body, probe and accessories.
① BT-220 main body and probe
② 1.5V Battery (2EA)
③ Ultrasound transmission gel (1EA)
④ Quick guide (1EA)
BT-220 Operation Manual 7
P/N : 220-ENG-OPM-EUR-R03
Bistos Co.,Ltd
2018.06
2.5 Exterior Component Designation
◎ Front View, Top View & Right View
◊
BT-220L
① Cust om Mono LCD
② Power and Mode Button, Speaker test and Up/Down Button
③ Charging Indicato r LED
④ Built-in speaker
⑤ Ear P hone Jack
◊
BT-220C
① TFT Color LCD
② Power and Mode Button, Speaker test and Up/Down Button
③ Charging Indicator LED
④ Built-in speaker
⑤ Electrode Plate
⑥ Ear Phone Jack
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P/N : 220-ENG-OPM-EUR-R03
Bistos Co.,Ltd
2018.06
◎ Rear View, Bottom View & Left View
① Product Label
② Battery Compartment
③ Probe Groove Joint
④ Probe Connection and Charging Jack
◎ Probe
① Sensor
② Probe Groove Joint
③ Probe Connect or
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