Bistos BT-220 User Manual

BT-220

Keep this manual for future reference

P/N: 220-ENG-OPM-EUR-R03

Operation Manual

.

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

th

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

Telephone: +82 31 750 0340 Fax: +82 31 750 0344

Printed in Korea

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

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

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

5

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

WARNING

EXPLOSION HAZARD - Do not use the BT-220 in a flammable atmosphere where

equipment.

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



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

BT-220 Operation Manual 4

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

CAUTION

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

clean and free of ultrasound transmission gel and other substances.

Avoid p lacing in an area

30% to 85%.

Do not disjoint or

it.

Power off when the

damaged.

1.3 Cautions



 Keep the operating environment free of dust, vibrations, corrosive, or flammable

materials, and extremes of temperature and humidity. The unit should be kept

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

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

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.

disassemble the equipment. BISTOS Co., Ltd. does not take responsibility of

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

BT-220 Operation Manual 5

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Symbol

Description

CAUTION

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

1.4 Definitions of Symbols

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.



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

BT-220 Operation Manual 8

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

BT-220 Operation Manual 9

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

◊

Button

Description

◊

Button

Description

Symbol

Description

Doppler volume mute indicator

Section 3

Operation

3.1 Controls and Indicators

3.1.1 Button and Description

BT-220L

Speaker test On/Off Volume Down

Volume Up Power On/Off

BT-220C

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

Battery indicator Doppler volume indicator

Low battery indicator

Battery charge indicator

BT-220 Operation Manual 10

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

◊

Symbol

Description

This mode displays fetal heart rate and heart rhythm with heart sound

This mode displays fetal hear t rate, heart rhythm and change of heart rate with heart sound

This mode set the unit of height, weight, and start mode.

charging

Completing the charging.

Blue LED is OFF.

Blue LED is ON.

General(2000mAh)

Under approx. 400 minutes

3.1.3 Mode and Description

BT-220C

FHR Number

FHR Graph

BMI calculation This mode displays the BMI BMI trend This mode displays saved data of BMI Unit setting

3.1.4 Battery Charging

If the voltage level of battery is lower than the req uired 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 yo u 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 time

* During the charging the device does not operating.

3.1.5 Automatic Shutdown

If the device is not used for 1 minute, it sto ps the heart sound with "b eep" sound , and shutdo wn in 3 minutes with another "beep" sound. If the battery voltage is dropped or the device being charged d ur in g t he use , the device will s hut 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.

BT-220 Operation Manual 11

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

◊

Ultrasound transducer

Search for the position which can get the clearest sound.

3.2 Operation of BT-220

3.2.1 LCD Display

BT-220L

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.

Press the volume up/do wn button to adjust the volume level (1~4).

BT-220 Operation Manual 12

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

◊

FHR Number mode

FHR Graph mode

BMI mode

BMI trend mode

Heart rhythm indicator

Heart rate (HR) value

Average HR value

Operating time of FHR

Function of button

Graph of HR

BT-220C

BT-220C has totally four modes. You can select the mode by pressing button for a short time.

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

③ ⑤

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 ti me of heat beat. The bold lines in graph region represent the stable heart rate.

② ④ ⑥

BT-220 Operation Manual 13

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

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.

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

BT-220 Operation Manual 14

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Function of button

Last measured data

Entered information

Body composition graph

⑤

Pop-up window for deleting data

Function of button

Start/Cancel

③

Entered information

①

③

② ④

2) Information Setting: P ress the It em Select: Press the

Change Value : Use the

button to enter the start menu.

button to select ite m (Se x, Age, HT, WT)

button to c hange the val ue.

(Information of age, height, and weight is not cleared)

①

②

If all i nfor mati on has be en modified or chan ged press mode button

to selec t [ST ART/CAN CEL]

menu.

3) Start Measurement: when the cursor is on [START CANCEL], press the measurement or press the

button to cancel (return to BMI mode).

button to start

BT-220 Operation Manual 15

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Function of button

Measured data

Last entered information

Graph of stored data

After pressing start, touch t he 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 a utomatically. Automatically measured HR, B M I, FAT is stored (up to 10).

4) Delete Data : Press the press

button to select the operation.

button to delete data. Use the button to select the menu and

3.2.4 BMI TREND

①

③

1) Mode Change: Press the

2) Stored Data Review: Press the

② ④

button shortly to change the mode to FHR numeric mode

button to see the stored data.

BT-220 Operation Manual 16

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Unit set value

Function of buttons

3.2.5 UNIT Setting

①

1) To enter unit s etting menu, press down the

2) Item select: Press the

3) Value Change: Press the

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 re turn to the current operating mode, press down the seconds.

button shortly

button.

②

button about 2 seconds.

button about 2

BT-220 Operation Manual 17

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

CAUTION

Check the main body and the probe thoroughly after cleaning.

CAUTION

Do not autoclave. Do not gas sterilize.

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.

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 t he b o dy and the p ro b e once a mo nt h. Do not use lac quer, thinner, ethylene, or the oxidizi ng 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.



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.



4.3 Battery Disposal and Handling



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.

BT-220 Operation Manual 18

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

General

Intensity

Less than 10mW/cm2

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 Characteristic s

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 shoc k

Internal powered equipment

Mode of operation

Continuous operation

Probe: IPX7 Main body: IPX0

Power

AA type 1.5V X 2 About 240 minutes (continuous use)

Environment

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㎪

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.

Ultrasound Frequency 2MHz, 3Mhz

Heart rate counting range

Main body

Protection level against electric shock Type BF

Protection against ingress of water

Battery

Operating Temperature Operating Humidity 30% ~ 85% non-condensing

(L)132㎜×(H)66㎜×(D)27.6㎜

10℃(50℉) to 40℃(104℉)

BT-220 Operation Manual 19

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

The BT-220 is intended for use in the electromagnetic environment specified below. environment.

Emissions test

Compliance

Electromagnetic environment-guidance

interference in nearby electr onic equi pment.

RF emissions CISPR 11

Harmonic emission IEC61000-3-2

Voltage fulctuations IEC61000-3-3

The BT-220 is intended for use in the electromagnetic environment in which radiated

maximum output power of the communications equipment.

Separation distance according to freque nc y of transmitter[M]

0.01

0.12

0.23

0.1

0.38

0.73 1

1.2

2.3

10

3.8

7.3

100

12

23

Section 6

Declaration on EMC

6.1 Electromagnetic emissions

The customer or the user of BT-220 should assure that it is used in such an

RF emissions CISPR 11

/flicker emissions

Group 1

Class B

Not applicable

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

The BT-220 is suitable for use in all establishments by using a battery.

6.2 Recommended separation distances between portable and mobile RF communications equipment and the BT-220

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

Rated maximum output power of transmitter [W]

150 kHz to

80 MHz

80 MHz to

800 MHz

800 MHz to

2.5 GHz

BT-220 Operation Manual 20

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

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

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

The BT-220 is intended for use in the electromagnetic environment specified below. environment.

IEC 60601 Test level

Compliance level

Electromagnetic environment-guidance

Floors should be wood,

at least 30%.

input/output lines

mode

<5%U

for 5s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the BT requires Continued operation during power mains interruptions, it is recommended that the BT 220 powered from a battery.

Power frequency magnetic

environment.

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. NOTE2) These guidelines may not apply in all situations. Electromagnetic propagation

6.3 Electromagnetic immunity

The customer or the user of the BT-220 should assure that it is used in such an

Immunity test

Electrostatic discharge(ESD) IEC 61000-4-2

Electrical fast transient/burst IEC61000-4-4

Surge IEC61000-4-5

±6 ㎸ Contact ±8 ㎸ air

±2 ㎸ for power supply lines

for

±1 ㎸

±1 ㎸ differential mode

common

±2 ㎸

±6 ㎸ Contact ±8 ㎸ air

Not applicable

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

Mains power quality should be that of a typical commercial or hospital environment.

T

(>95% dip in UT)

for 0.5 cycle Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11

Power frequency (50/60 ㎐)

magnetic field IEC61000-4-8

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

40% U

T

(60% dip in UT)

for 5 cycle

70% U

T

(30% dip in U

Not applicable

)

T

for 25 cycle

<5% U

T

(<95% dip in UT)

3 A/m 3 A/m

-220 image intensifier

image. Intensifier be

fields should be at levels characteristic of a typical commercial or hospital

-

BT-220 Operation Manual 21

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

The BT-220 is intended for use in the electromagnetic environment specified below. environment.

IEC 60601 test

level

Compliance

level

Electromagnetic environment-

guidance

Conducted

3 V

3 V/m

Portable mobile RF ommunications

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

Over the frequency range 150

kHz

to 80

MHz

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

The customer or the user of the BT-220 should assure that it is used in such an

Immunity test

RF IEC 61000-46

Radiated RF IEC 61000-4-

rms

150

3 V/m

MHz

80

3

kHz

~ 80

~ 2.5

MHz

3 V/m

equipment should be used no closer to any part of the BT- 220, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

80

MHz

~ 800

800

MHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and recommended separation distance in meters(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol:

~ 2.5

b

.

MHz

GHz

d

a

, should

is the

cannot be predicted theoretically with accuracy. To assess the elec tromagnetic 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-220 is used exceeds the applicable RF compliance level above, the BT-220 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orie ntin g or relo cat ing the BT-

220.

b

BT-220 Operation Manual 22

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Image at Frequency of Interest

Frequency of Interest**

Actual Immunity Level

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system ambient background noi ** Between 80 MHz ~ 158.95 MHz, 162.14 MHz ~ 199.82 MHz and 203.84 MHz ~

2.5 GHz the level of Immunity is 3 V/m.

from the System Ambient

6.4 Immunity and Compliance Level

[Probe : AY-2MHZDOP-220C (2 Hz, Vertical)]

[MHz]

160.54 MHz 3 V/m

Radiated RF

IEC 61000-4-3

se.

201.82 MHz 3 V/m

Frequency of Interest

[MHz]

F1 = 160.54 F1 = 201.82

Image at Frequency of

Interest

Voltage Level at which

the RF Induced Noise is

No Longer Discernable

Background Noise

1.6 V/m 2.6 V/m

BT-220 Operation Manual 23

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Image at Frequency of Interest

Frequency of Interest**

Actual Immunity Level

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system ambient background noise. ** Between 80 MHz ~ 81.60 MHz, 83.24 MHz ~ 151.23 MHz, 154.27 MHz ~ 214.24 MHz and

218.54 MHz ~ 2.5 GHz the level of Immunity is 3 V/m.

Interest [MHz]

Voltage Level at

Ambient

Probe : AY-2MHZDOP-220C (2 Hz, Horizontal)]

[MHz]

82.42 MHz 3 V/m

152.74 MHz 3 V/m

Radiated RF IEC 61000-4-3

Frequency of

Image at

Frequency of

Interest

which the RF

Induced Noise is

No Longer

Discernable from

the System

F1 = 82.42 F1 = 152.74 F1 = 216.38

2.4 V/m

216.38 MHz 3 V/m

1.6 V/m

2.8 V/m

BT-220 Operation Manual 24

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Image at Frequency of

Interest

Frequency of Interest**

[MHz]

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system ambient background noise. ** Between 80 MHz ~ 115.60 MHz, 117.92 MHz ~ 119.10 MHz and 121.50 MHz ~ 2.5 GHz the level of Immunity is 3 V/m.

the RF Induced Noise is

from the System Ambient

[Probe : AY-3MHZDOP-220C (2 Hz, Vertical)]

Actual Immunity Level

116.76 MHz 3 V/m

120.30 MHz 3 V/m

Radiated RF IEC 61000-4-3

Frequency of Interest

[MHz]

F1 = 116.76 F1 = 120.30

Image at Frequency of

Interest

Voltage Level at which

No Longer Discernable

Background Noise

2.4 V/m

2.8 V/m

BT-220 Operation Manual 25

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Image at Frequency of

Interest

Frequency of Interest**

[MHz]

* Voltage Level at which the RF Induced Noise is No Longer Discernable from the system ambient ** Between 80 MHz ~ 155.81 MHz, 158.95 MHz ~ 227.42 MHz, 231.99 MHz ~

274.75 MHz and

280.27 MHz ~ 2.5 GHz the level of Immunity is 3 V/m.

Interest [MHz]

Voltage Level at

Ambient

[Probe : AY-3MHZDOP-220C (2 Hz, Horizontal)]

Actual Immunity Level

157.37 MHz 3 V/m

229.69 MHz 3 V/m

Radiated RF IEC 61000-4-3

background noise.

Frequency of

Image at

Frequency of

Interest

which the RF

Induced Noise is

No Longer

Discernable from

the System

F1 = 157.37 F1 = 229.69 F1 = 277.49

1.4 V/m

277.49 MHz 3 V/m

2.2 V/m

2 V/m

BT-220 Operation Manual 26

P/N : 220-ENG-OPM-EUR-R03

Bistos Co.,Ltd

2018.06

Product Name

Fetal Doppler

Model Name

BT-220

Serial No.

Warranty Period

1 Years (Probe excluded)

Date of Purchase

Hospital:

Telephone:

Sales Agency

Manufacture

Bistos Co., Ltd.

Product Warranty

Customer

Address: Name:

※ Thank you for purchasing BT-220. ※ 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.

Service Telephone and Fax. Numbers

Telephone: +82 31 750 0340

Fax: +82 31 750 0344

th

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

7

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