Bistos BT-200 User Manual (2025)

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

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.

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7

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-200 Operation Manual

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

6

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

BT-200 Operation Manual

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



BT-200 Operation Manual

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: