BT-200(Hi-bebe)
Fetal Doppler
Operation manual
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BT-200
Keep this manual for future reference
P/N: 200-ENG-OPM-EUR-R06
BT-200 Operation Manual |
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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: +82 31 750 0340
Fax: +82 31 750 0344
Printed in Korea
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P/N: 200-ENG-OPM-EUR-R06 |
Bistos Co.,Ltd |
2018,03 |
BT-200 Operation Manual |
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Table of Contents
1. SAFETY ........................................................................................... |
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1.1 |
Instructions for the Safe Operation and Use of the BT-200 .......................................... |
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1.2 |
Warnings ......................................................................................................................... |
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1.3 |
Cautions .......................................................................................................................... |
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1.4 |
Definitions of Symbols ................................................................................................... |
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2. INTROCUTION .................................................................................. |
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2.1 |
Intended use .................................................................................................................... |
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2.2 |
Indications for Use.......................................................................................................... |
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2.3 |
Product Configuration..................................................................................................... |
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2.4 |
Exterior Component Designation.................................................................................... |
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3. |
OPERATION ...................................................................................... |
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3.1 |
Operation requirements................................................................................................... |
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3.2 |
How to use? .................................................................................................................... |
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3.3 |
Basic clinical information ............................................................................................... |
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3.4 |
Maintenance and cleaning............................................................................................... |
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4. |
GENERAL INFORMATION AND SPECIFICATIONS ...................... |
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5. |
DECLARATION ON EMC ................................................................ |
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5.1 |
Electromagnetic emmission .......................................................................................... |
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5.2Recommended separation distances between portable and mobile RF communications
equipment and the BT-200........................................................................................... |
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5.3 Electromagnetic immunity............................................................................................ |
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PRODUCT GUARANTEE ...................................................................... |
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P/N: 200-ENG-OPM-EUR-R06 |
Bistos Co.,Ltd |
2018,03 |
BT-200 Operation Manual |
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Section 1 Safety
1.1Instructions 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 |
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the “Caution” sign. |
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NOTE |
Be informed that it may cause a potential hazardous situation which, if |
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not avoided, may result in minor or moderate injury. |
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P/N: 200-ENG-OPM-EUR-R06 |
Bistos Co.,Ltd |
2018,03 |
BT-200 Operation Manual |
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1.2 Warnings
WARNING |
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EXPLOSION HAZARD - Do not use the HI•bebe Doppler BT-200 in a |
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flammable atmosphere where concentrations of flammable anesthetics |
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or other materials may occur. |
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SHOCK HAZARD - HI•bebe Doppler BT-200 doesn't have protection |
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against the burn injury caused by RF Surgical equipment. Do NOT use |
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this product along with RF Surgical equipment. |
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Use of cable or accessories which do not supplied or specified by |
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manufacturer can cause degrade of EMC characteristics or negative |
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effect on HI•bebe Doppler BT-200. |
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HI•bebe Doppler BT-200 should not be used any active implantable or |
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bodyworn medical device, including pacemakers, ICDs, |
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neurostimulators, and insulin pumps simultaneously. |
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No modification of this device is allowed. Do not modify this device |
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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 |
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physician. |
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Keep the operating environment free of dust, vibrations, corrosive, or |
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flammable materials, and extremes of temperature and humidity. The |
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unit should be kept clean and free of transducer gel and other |
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substances. |
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HI•bebe Doppler BT-200 classified as internally powered equipment |
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according to IEC 60601-1 Medical Electrical Equipment - Part 1: General |
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requirements for basic Safety and essential performance |
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HI•bebe Doppler BT-200 is classified as Class B according to IEC60601- |
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1-2 Medical Electrical Equipment - Part 1-2 : General requirements for |
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basic Safety and essential performance – Collateral standard: |
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Electromagnetic compatibility |
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P/N: 200-ENG-OPM-EUR-R06 |
Bistos Co.,Ltd |
2018,03 |
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