Related Manuals for Bistos BT-1000
Summary of Contents for Bistos BT-1000
- Page 1 BT-1000 Operation manual BT-1000 Keep this manual for future reference P/N: 1000-ENG-OPM-USA-R01...
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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 ................23 7.1. Electromagnetic emissions ....................23 7.2. Recommended separation distances between portable and mobile RF communications equipment and the BT-1000 ....................... 23 7.3. Test specifications for enclosure port immunity to RF wireless communications equipment ..........................24 7.4. -
Page 4: Safety Information
Used to display safety information for Safety colours and safety signs — warnings. Registered safety signs / W001 Before using the BT-1000, please be fully understand the information provided with the device. ISO 15223-1, Medical Devices— Used to identify safety information for Symbols to be used with medical caution. - Page 5 BT-1000 Operation Manual 15223-1, Medical Devices— Symbols to be used with medical device labels, labeling and information Indicates the serial number of the device. 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
BT-1000 Operation Manual be returnable to your distributor for recycling - contact the distributor for details. 15223-1, Medical Devices— Do not re-use Symbols to be used with medical device labels, labeling and information Indicates a medical device that is to be supplied – Part 1: General intended for one single use only requirements / 5.4.2... - Page 7 Bistos will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to qualified service personnel in parts repair. BT-1000 should be kept out of the reach of infants and children under the age of 7 years. ...
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Page 8: General Precaution On Environment
Power off when the Do not disjoint or equipment is not fully disassemble the installed. equipment. Otherwise, the BISTOS Co., Ltd. does not equipment could be take responsibility of it. damaged. P/N: 1000-ENG-OPM-USA-R01 Bistos Co.,Ltd 2024.11... -
Page 9: Introduction
The BT-1000 is a medical device that is not connected to any other device or networks. It is used only in a single location, it does not transmit or communicate any data. - Page 10 BT-1000 Operation Manual • The composition of BT-1000 is as shown below. Name Description Electronic stimulation signal setting status, ① LCD display stimulation status, Error information display ② Power button Main body power ON/OFF ③ Button(Up) ④ Button (Left) Left ⑤...
- Page 11 BT-1000 Operation Manual CAUTION The device applies only one channel to one patient. One channel is used for stimulation and the other channel is for reserve. • Display Description Figure Name Description Boot process and logo display Boot when power on...
- Page 12 BT-1000 Operation Manual RUN – move to Operation screen Start menu Channel Setting – move to Stimulation Setting menu screen - CH1, CH2: Set Stimulation channel 1 or 2 On/Off - Current: Setting the stimulation Stimulation signal current level (1.0 Setting 10.0mA)
- Page 13 BT-1000 Operation Manual - Pause state while displaying the play button - Run status while displaying the pause button Power Off Power Off indication Key Hold and LCD Off during Hold Operation When the charging cable is connected, Battery Charge Functions of the device cannot be operated.
- Page 14 Liner, Electrode, Lead wire Shelf-life 2 years (from the date of manufacture) CAUTION Use only electrode supplied by Bistos Co., Ltd. Use of accessories not provided may result in personal injury or equipment damage. P/N: 1000-ENG-OPM-USA-R01 Bistos Co.,Ltd...
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Page 15: Operation
3. Operation 3.1. Operating Principle The operating principle of the BT-1000 external Trigeminal Nerve Stimulation System involves the delivery of low-level electrical pulses to the trigeminal nerve via an electrode placed on the forehead. The electrical pulses are generated by a controller unit and transmitted by wire to the electrode patch. -
Page 16: Enter Password
BT-1000 Operation Manual 3.2.2 Enter Password • Enter the four passwords following the prompt you set before with a combination of five input buttons Up, Down, Select, Left, Right. Device default password is • If the password matches move to the start window automatically. -
Page 17: Electrode Connect
BT-1000 Operation Manual • When the parameters are set, move to the Run menu with the up and down buttons and press the select button (Section 3.2.5) to move to the Operation window. < Simulation Setting > 3.2.5 Electrode connect •... -
Page 18: Operation Window, Hold Window
BT-1000 Operation Manual 3.2.6 Operation window, Hold window • Check the setting values such as Current and Duration again before outputting the electrical stimulation signal. • When you enter the operation window, the default is pause mode, and run menu appears at the bottom of the window and ready to run. -
Page 19: System Setting Window
BT-1000 Operation Manual < Hold > 3.2.7 System Setting window • In the Start window, press the Select and Down buttons to move to the System Setting window. < System setting > • Move to the menu you want to change with the Up, Down buttons •... -
Page 20: Power Off
< Power Off > 3.3. Recommendation of the treatment Bistos recommends to use the device with setting intensity to 2-4mA if there is no minor uncomfortable sensation such as itching or tingling for at least 8 hours during sleep. Consult your physician for recommended duration of treatment. -
Page 21: Cleaning And Disinfection
• The device and accessories do not require periodic calibration or adjustment. • Do not operate the device if it fails to pass the power on self-test procedure. Contact Bistos Service Center. • When the displayed condition is not stable, check the battery and charge them. - Page 22 If the leaked liquid splashes into your eyes, do not wipe them. Irrigate them with clean water first and go to see a doctor immediately. Shelf-life is not applicable to this BT-1000 because of low likelihood of time-dependent product degradation. P/N: 1000-ENG-OPM-USA-R01 Bistos Co.,Ltd...
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Page 23: General Information And Specifications
BT-1000 Operation Manual 6. General information and specifications Physical Characteristics Dimensions (L)148.0 mm X (D) 78.0 mm X (H) 48.0 mm Weight Approx. 200 g Display type LCD (TFT Color LCD) Safety Standard EN 60601-1, EN 60601-1-2, EN 60601-1-11 Classification... -
Page 24: Declaration On Emc
7.2. Recommended separation distances between portable and mobile RF communications equipment and the BT-1000 The BT-1000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the P/N: 1000-ENG-OPM-USA-R01 Bistos Co.,Ltd... -
Page 25: Test Specifications For Enclosure Port Immunity To Rf Wireless Communications Equipment
The BT-1000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Portable RF communications equipment should be used no closer than 30cm (12 inches) to any part of the BT-1000. Otherwise, degradation of the performance of this equipment could result. -
Page 26: Electromagnetic Immunity
7.4. Electromagnetic immunity The BT-1000 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-1000 should assure that it is used in such an environment. IEC 60601 Electromagnetic... - Page 27 The BT-1000 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-1000 should assure that it is used in such an environment. IEC 60601 test...
- Page 28 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BT-1000 is used exceeds the applicable RF compliance level above, the BT-1000 should be observed to verify normal operation.
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Page 29: Product Guarantee
Telephone: Sales Agency Manufacture Bistos Co., Ltd. ※ Thank you for purchasing BT-1000. ※ 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.
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