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Summary of Contents for Bistos BT-200L
- Page 1 Ultrasound Doppler System Operation manual BT-200L, BT-200T, BT-200V Keep this manual for future reference 200-ENG-OPM-EUR-R12...
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Page 2: Proprietary Material
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. -
Page 3: Table Of Contents
BT-200L/T/V Operation Manual Contents 1. SAFETY INFORMATION ......................3 1.1. Instructions for the Safe Operation and Use ..............3 1.2. Warnings .......................... 5 1.3 General Precaution on Environment .................. 6 2. INTRODUCTION ........................6 2.1. Intended use ........................6 2.2. Device description ......................6 2.3. -
Page 4: Safety Information
BT-200L/T/V Operation Manual 1. Safety information 1.1. Instructions for the Safe Operation and Use Symbols used: The following symbols identify all instructions that are important to safety. Failure to follow these instructions can lead to injury or damage to the device. When used in conjunction with the following words, the symbols indicate: Can lead to serious injury or product/property damage. - Page 5 BT-200L/T/V Operation Manual 15223-1, Medical Devices— Symbols to be used with medical Indicates the serial number of the device labels, labeling device. information to be supplied – Part 1: General requirements / 5.1.7 15223-1, Medical Devices— Symbols to be used with medical...
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Page 6: Warnings
Do not disassemble or modify the device. The device only has the specified safety and performance when it is manufactured by the manufacturer. • Do not attempt to repair the device. Only qualified service personnel by Bistos Co., Ltd. should perform. •... -
Page 7: General Precaution On Environment
2. Introduction 2.1. Intended use The HI•bebe, BT-200L/T, and HI•dop, BT-200V are pocket-size fetal Doppler intended to the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well-being; and output the sound of fetal heart beat through built-in speaker. -
Page 8: Product Configuration
BT-200L/T/V Operation Manual 2.3. Product Configuration The ultrasound Doppler system consists of the following. Unpack the package and check out the following items. Also be sure to check any damage of the monitor, probe and accessories. ① The monitor and probe (Refer to the below table) ②... - Page 9 BT-200L/T/V Operation Manual BT-200L BT-200T BT-200V Series 1.5V battery 1.5V battery 1.5V battery Power *2 (AA Type) *2 (AA Type) *2 (AA Type) Battery life 280min. 280min. 280min. 2.4. Exterior Component Designation ◎ Front View & Top View ① Power and Volume Switch ②...
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Page 10: Operation
BT-200L/T/V Operation Manual ◎ Probe ① Transducer ② Groove joint 3. Operation 3.1. Operation requirements • The ambient temperature and humidity of the HI • bebe should to be 10℃∼40℃ and 30% ~ 85％. • Handle with care. • Avoid dust or flammable materials. -
Page 11: Display
Operation Manual • If use 2,3 MHz probe of BT-200L, BT-200T and BT-200V, place the probe on the measurement area at a 90-degree angle (see figure 2.) and move slowly to locate the point where fetal heart sounds are at the maximum. Or place the transducer directly against the abdomen, just above the point where the pelvic bones meet. -
Page 12: Cleaning And Disinfection
BT-200L/T/V Operation Manual Turn the monitor on and verify that the normal monitoring screen appears on the display. Do not use the device if an error occurs. Check is powered from the AA battery. Apply ultrasound gel to the face of the transducer. -
Page 13: Contacting Components
BT-200L/T/V Operation Manual (5) Wipe the transducer three (3) times with sterile water to remove Cidex™ residue. (6) Dry the device thoroughly with a sterile soft towel or gauze surgical sponge. (7) Wrap the dry transducer with a fresh sterile soft towel or transparent sterile wrap for storage until next use. -
Page 14: Ultrasound Transducer Test
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. General MI and TI values do not exceed 1.0. -
Page 15: Declaration On Emc
190 g Electrical safety Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37 Internally powered equipment Type BF applied parts BT-200L/T Probe waterproof Level IPX7 BT-200V Probe waterproof Level IPX2 Power 1.5V X 2 (AA type) Battery About 280 minutes for continuously use... -
Page 16: Electromagnetic Emissions
BT-200L/T/V Operation Manual Use of accessories including probe and cables other than those specified or provided by the ⚫ manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. -
Page 17: Electromagnetic Immunity
BT-200L/T/V Operation Manual 0.38 0.38 0.73 For transmitters rated at a maximum output power not listed above, the recommended 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. - Page 18 BT-200L/T/V Operation Manual Power frequency 30 A/m 30 A/m Power frequency magnetic (50 Hz and 60 Hz) fields should be at levels magnetic field characteristic of a typical location in a typical IEC 61000-4-8 commercial or hospital environment. series The BT-200 is intended for use in the electromagnetic environment specified below.
- Page 19 BT-200L/T/V Operation Manual 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 cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
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Page 20: Product Guarantee
BT-200L/T/V Operation Manual Product Guarantee Product Name Ultrasound Doppler System Brand Nam HI•bebe / HI•dop Model Name BT-200L, BT-200T, BT-200V Approval No. Approval Date Serial No. Warranty Period 1 Years (Probe excluded) Date of Purchase Hospital: Address: Customer Contact Name:...
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