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Summary of Contents for Bistos HI-bebe S
- Page 1 HI-bebe S Operation manual BT-220C Keep this manual for future reference P/N: 220C-ENG-OPM-EUR-R06...
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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
7. DECLARATION ON EMC ................17 7.1 Electromagnetic emissions ................... 18 7.2 Recommended separation distances between portable and mobile RF communications equipment and the BT-220C ..................18 7.3 Electromagnetic immunity .................... 19 PRODUCT GUARANTEE ................. 22 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03... -
Page 4: Safety Information
Indicates the serial number of the device labels, labeling device. information to be supplied – Part 1: General requirements / 5.1.7 ISO 15223-1, Medical Devices— Indicates the authorized Symbols to be used with medical representative in the European 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03... -
Page 5: Warnings
Do not use the device without consultation of medical professional. • The relevant law restricts this device to sale by or on the order of a physician. • Use the Bistos original accessories. • Do not touch or operate the device with wet hands to avoid electric shock. •... - Page 6 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 repair the device.
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Page 7: General Precaution On Environment
2. Introduction 2.1. Intended use The HI-bebe S, BT-220C is a pocket-size fetal doppler intended to the detection of fetal heart rate from early gestation to delivery and as a general indication of fetal well-being. Fetal heart rate is displayed on a color LCD display, and its sound is output through a built in speaker. -
Page 8: Product Configuration
IPX7 Water proof Probe Detachable type type AY-DOP-220(2M) Available accessories AY-DOP-220(3M) Audio output 1 W speaker, 3.5mm phone jack Sound mute: 1 min. Auto shut off Power off: 3 min. 1.5V battery *2 Power (AA Type) 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03... -
Page 9: Exterior Component Designation
Power On/Off button ⑥ Built-in speaker ⑦ Ear phone jack ◎ Rear, Bottom & Right View ① Product label ② Battery compartment with cover ③ Groove joint for holding probe ④ Connection part to probe ◎ Probe 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03... -
Page 10: Operation
Sensor cover ② Tongue for holding probe 3. Operation 3.1. Operation requirements • The ambient temperature and humidity of the HI-bebe S should be 10°C∼40°C and 30% ~ 85％. • Handle with care. • Avoid dust or flammable materials. •... - Page 11 This mode displays saved data of BMI This mode set the unit of height, weight, and start Unit setting mode. 3.2.2. HI-bebe S Mode • BT-220C has totally four modes. You can select the mode by pressing button for a short time.
- Page 12 Speaker test operation (FHR graph → AST): Press the • button shortly. < AST Operation> Use the button for generating sound. The sound is generated only at speaker. AST1 has 75 Hz and AST2 has 100 Hz frequency. 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03...
- Page 13 If all information has been modified or changed press mode button to select [START/CANCEL] menu. • Start Measurement: when the cursor is on [START CANCEL], press the button to start measurement or press the button to cancel (return to BMI mode). • 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03...
- Page 14 ④ Graph of stored data Last entered information • Mode Change: Press the button shortly to change the mode to FHR numeric mode. • Stored Data Review: Press the button to see the stored data. 3.2.2.4. UNIT Setting 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03...
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Page 15: Basic Clinical Information
Verify the monitor is displaying fetal heart rate values and that the heart rhythm indicator on the screen is solid and blinking at the measured heart rate. ➢ Step 3: Monitor Adjustments Readjust the volume settings for the desired loudness. 4. Cleaning and disinfection 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03... -
Page 16: Monitor
4.4 Description of Cidex (1) Cidex is FDA-cleared for use in the United States. Therefore we suggest that the disinfection effect using Cidex is valid. (2) FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03... -
Page 17: Troubleshooting And Maintenance
If the operation time is not long enough, please change the battery. WARNING User can open the battery compartment to replace the battery, and use 2 of AA type ⚫ 1.5V batteries. 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03... -
Page 18: General Information And Specifications
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 19: Declaration On Emc
EMC information provided in this user manual. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect the Hi-bebe S and should be kept at least 1 m away from the equipment. -
Page 20: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Bt-220C
The BT-220C is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-220C should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity test Compliance level Test level environment-guidance 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03... - Page 21 Electromagnetic environment- Immunity test Compliance level level guidance Conducted RF 3 V/m Portable mobile RF communications IEC 61000-4-6 150 kHz ~ 80 MHz equipment should be used no closer to any part of the BT-220C, including 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03...
- Page 22 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the BT-220C. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03...
- Page 23 BT-220C Operation Manual 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03...
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Page 24: Product Guarantee
Telephone: Sales Agency Manufacture Bistos Co., Ltd. ※ Thank you for purchasing HI-bebe S. ※ 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. - Page 25 BT-220C Operation Manual 220C-ENG-OPM-EUR-R06 Bistos Co.,Ltd 2025.03...
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