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
1
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
Copyright © Bistos Co., Ltd. 2017. All rights reserved.
th
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
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P/N: 200-ENG-OPM-EUR-R06
Bistos Co.,Ltd
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
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
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P/N: 200-ENG-OPM-EUR-R06
Bistos Co.,Ltd
2018,03
•
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
BT-200 Operation Manual
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P/N: 200-ENG-OPM-EUR-R06
Bistos Co.,Ltd
2018,03
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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