Bistos BT-200 User Manual

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BT-200(Hi-bebe)

Fetal Doppler

Operation manual

BT-200

Keep this manual for future reference

P/N: 200-ENG-OPM-EUR-R06

Page 2

BT-200 Operation Manual

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

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

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BT-200 Operation Manual

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2018,03

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 ...................................................................................................

2. INTROCUTION .................................................................................. 7

2.1 Intended use .................................................................................................................... 7

2.2 Indications for Use .......................................................................................................... 7

2.3 Product Configuration ..................................................................................................... 7

2.4 Exterior Co mponent Designation .................................................................................... 8

3. OPERATION ...................................................................................... 9

3.1 Operation requirements ................................................................................................... 9

3.2 Ho w 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 a nd the BT-200 ........................................................................................... 11

5.3 Electromagnetic immunity ............................................................................................ 12

PRODUCT GUARANTEE ...................................................................... 14

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•

procedure.

Be informed that it may cause no harm in life but lead to injury against the “Caution” sign.

Be informed that it may cause a potential hazardous situation which, if not avoided, may result in minor or moderate injury.

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

CAUTION



NOTE



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EXPLOSION HAZARD - Do not use the HI•bebe Doppler BT-200 in a

safe use of device.

The relevant law restricts this device to sale by or on the order of a

Electromagnetic compatibility

1.2 Warnings

WARNING

1.3 Cautions

CAUTION



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



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:

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Avoid placing in an area

ranges from 30% to 85%.

Power off when the

damaged.

General Precaution on Environment

 Do not keep or operate the equipment under the environment listed below.

exposed to moisture. Do not touch the equipment with wet hand.

where there is a high variation of temperature. Operating temperature ranges from 10°C to 40°C. Operating humidity

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 equipment. BISTOS Co., Ltd. does not take responsibility of it.

Avoid exposure to direct sunlight

Avoid in the vicinity of Electric heater

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

Avoid dust and especially metal material into the equipment.

equipment is not fully installed. Otherwise, the equipment could be

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Symbol

Description

This symbol indicates the authorized representative in the European

This symbol indicates the temperature limitation for operation,

This symbol indicates the compliance with the essential requirements

components, do not dispose as general

his symbol means an item is known to pose hazards in all MRI

1.4 Definitions of Symbols

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

※ 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.

This symbol indicates the manufacturer.

This symbol indicates the serial number of the device.

Community of manufacturer.

transport and storage.

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

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

When disposing of some wastes. Adhere to all applicable laws regarding recycling.

environments.

CAUTION

Federal law restricts this device to sale by or on the order of a physician.

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Heart rate

range(bpm)

Ultrasound frequency

(MHz)

probe

Water proof

Probe

type

Non-

detachable

Non-

detachable

Non-

detachable

Non-

detachable

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.

① BT-200 main body and probe(Refer to the below table) ② 1.5V Battery(2EA) ③ Ultrasound transmission gel (1EA) ④ User’s manual (1EA) ⑤ Carrying case(pouch, 1EA)

BT-200 series comparison table

Display

Series 200S 200L 200T 200C

LCD type None Mono LCD Mono LCD Color LCD

Not displayed 50~240 ±2% 50~240 ±2% 50~240 ±2%

2 2 3 2

IPX7 IPX7 IPX7 IPX7

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◎

2.4 Exterior Component Designation

Front View & Top View

① Power and Volume Switch ② Ear phone jack ③ Ring for necklace ④ Probe holder

⑤ LCD display

Rear View

① Battery compartment ② Label ③ Ring for necklace ④ Power and Volume Switch

Probe

① Transducer ② Groove joint

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Power

on LED

Heart

Rhythm

Battery

Low

FHR

Battery

Heart Rhythm

FHR

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,

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

 Do not under any circumstances immerse the device in cleaning fluid.

please seek advice from your obstetrician.

these could damage the device.

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General

Ultrasound center frequency

Refer to the comparison table on page 7

Heart rate range

50~240 bpm

(L)75㎜×(H)128㎜×(D)26㎜

200S/C/L/T: (L)27.8㎜ X (H)160.25㎜X (D)27.8

Probe waterproof Level IPX7 ,IPX2

Power

1.5V X 2 (AA type) About 280 minutes for continuously use

Operation

Storage

10℃(50℉) ~ 40℃(104℉)

-20℃(14℉) ~ 60℃(131℉)

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.

Intensity <10 mW/cm2

FHR accuracy ±2% of range

Sensitivity 10 ~ 12 weeks onward

Physical characteristics

Main body

Probe

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

Battery

Environmental conditions

Temperature

Relative Humidity 30% ~ 85% non-condensing

Atmospheric pressure

㎜

200V : (L)25 ㎜ X (H) 131/139 ㎜ X (D) 25 ㎜

79.051 ㎪ ~ 101.325 ㎪

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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

The BT-200 uses RF energy only for its

RF emissions CISPR 11

The BT-200 is suitable for use in all

Harmonic emission IEC61000-3-2

Voltage fulctuations

IEC61000-3-3

The BT-200 is intended for use in an electromagnetic environment in which

maximum output power of the communications equipment.

Separation distance according to frequency of transmitter[M]

150 kHz

 = 1,2√

80 MHz to

 = 1,2√

800 MHz to

 = 2,3√

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

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

affected by absorption and reflection from structures, objects and people.

Section 5 Declaration on EMC

5.1 Electromagnetic emissions

RF emissions CISPR 11

/flicker emissions

Group 1

Class B

Not applicable

internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

establishments by using a battery.

5.2 Recommended separation distances between portable and mobile RF communications equipment and the BT-200

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

Rated maximum output power of transmitter [W]

to 80MHz

800 MHz

2.5 GHz

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

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IEC 60601 Test level

Electromagnetic environment-guidance

Electrostatic

±6 kV Contact

Floors should be wood,

Electrical fast

±2 kV for power

Mains power quality should

Surge

±1 kV line(s) to

Mains power quality should

Voltage dips, short

< 5 % Uт

for 5 s

Mains power quality should

Power frequency

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

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

±8 kV air

supply lines ±1 kV for input/output lines

line(s) ±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

)

Compliance level

±8 kV air

Not applicable

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

be that of a typical commercial or hospital environment.

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 BT200 image intensifier be powered from a battery.

(50 Hz and 60 Hz) magnetic field

IEC 61000-4-8

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

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The The

IEC 60601 test

level

Electromagnetic environment-

guidance

Conducted RF

3 V

3 V/m

Portable mobile RF communications

transmitter manufacturer and d is the

NOTE 1) At 80

MHz

and 800

MHz,

the higher frequency range applies.

affected by absorption and reflection from structures, objects and people.

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

Over the frequency range 150

kHz

to 80

MHz

, field strengths should be less than 3 V/m.

BT-200 is intended for use in the electromagnetic environment specified below.

customer or the user of the BT-200 should assure that it is used in such an environment.

Immunity test

IEC 61000-4-6

Radiated RF IEC 61000-4-3

rms

150

kHz

3 V/m

MHz

~ 80

~ 2.5

MHz

Compliance level

3 V/m

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  = 2,3

√ √ √

  

80 800

MHz

~ 800

~ 2.5

MHz

GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the

recommended separation distance in meters(m). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey, be less than the compliance level in each frequency range.

should

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

NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is

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.

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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

Product Guarantee

Hospital:

Address:

Customer

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: +82 31 750 0340

Fax: +82 31 750 0344

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

Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea

Bistos Co., Ltd.

www.bistos.co.kr

bistos@bistos.co.kr

Obelis s.a

Bd. Général Wahis 53

1030 Brussels, BELGIUM

Telephone: + (32) 2. 732.59.54

Fax.: + (32) 2.732.60.03