Instruction manual Forehead Sleep Recorder Specification Developer: Shenzhen BrainScience Bio-Info Technology Co., LTD. Address: 1401, Building 7A, Wanke Yuncheng, Dashi 1 Road, Nanshan District, Shenzhen City, Guangdong Province, China. Zip Code: 518057 Web site: http://www.eegsmart.com/contact.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 Content 1. Declaration ........................................................................................................................ 3 2. Description ........................................................................................................................ 3 3. Revision record ................................................................................................................. 4 4. Customer Service ........
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 1. Declaration This manual is a reference for product operation, maintenance and repair. The user should strictly follow the instructions under the guidance of the physician. For failures or accidents caused by failure to operate in accordance with the instructions, Shenzhen BrainScience Bio-Info Technology Co., LTD. (hereinafter referred to as "the company") does not assume any legal responsibility.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 3. Revision record Product manual version: A0 Product manual issued date: 2019-06-18 Embeded software name: Umind sleep firmware Embeded software version:V1.0 Embeded software issued date: 2019-06-05 Application software name: Sleep recorder Application software version: V1.0 Application software issued date: 2019-06-12 4. Customer Service Company name: Shenzhen BrainScience Bio-Info Technology Co.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 consult their healthcare provider. 12) Warning: Do not wear it continuously for more than 12 hours. Check the forehead skin condition at least once every 12 hours, and do not continue to use without intervals of more than one hour. 13) Don’ t stare at the red light. 14) Place the device properly to avoid child can reach. 5.2. Cautions 1) 2) 3) 4) 5) 6) The electrode sticker is a single-use product and forbidden to be reused.
Forehead Sleep Recorder barometric pressure File No. DMR-SM902-4-25 700hPa～1060hPa 700hPa～1060hPa 5.5. Warning symbol Table2 description table for warning symbol Symbol Description IEC60601-1 BF type applied part Represent product series number Represent product lot number Model number General warning sign Must follow the product manual for use Nonionizing radiation Separate the collection for electronic equipment Production date Product manufacturer Direct current Support Bluetooth 4.
Forehead Sleep Recorder Rx only File No. DMR-SM902-4-25 Ver:A0 Federal Law (USA) restricts this device to sale by, or on the order of, a physician or other qualified healthcare practitioner licensed by the law of the state in which he or she practices to use or order the use of this device. 6. Product basic information This product is a Class II, type BF, internally powered, medical device and is rated for continuous operation. 6.1. The device 6.1.1. Product name: Forehead sleep recorder 6.1.2.
Forehead Sleep Recorder File No. DMR-SM902-4-25 RF Band Width 2402MHz～2480MHz Data rate 1Mbps Occupied ban wide 2MHz Channel separation 2MHz Maximum transmission distance 2m Ver:A0 6.2. Accessory 1: Product name: electrode Model number: EP3 Specification developer: Shenzhen BrainScience Bio-Info Technology Co.
Forehead Sleep Recorder 4) 5) 6) File No. DMR-SM902-4-25 Ver:A0 USB Charging cable Manual Warranty card 6.6. Product formation 6.6.1. Device Figure 1 ①Power button 6.6.2. ②Indicator ③EEG electrode ④Window for Pulse rate and SpO2 Charging box Figure 2 ①Transparent window ②Mirror ③Electrode cabin ④Charging dock ⑤Magnetic fastener ⑥Micro-USB Charging socket 6.6.3. Electrode Figure 3 9 / 23 Copyright© Shenzhen BrainScience Bio-Info Technology Co.
Forehead Sleep Recorder File No. DMR-SM902-4-25 ①Front side ②Back side ③Snap fastener Ver:A0 ④Conductive gel 6.7. Product function This product has following function Table 5- Product function list Function EEG Description Monitoring and record the EEG data generated during sleep Body position Monitoring and recorder the sleep position: upright, left lateral, right lateral, supine, prone position Body motion Class the motion frequency in sleep to different grade.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 Before each use of this product, the smart mobile device or tablet running the APP for the product should be fully charged to ensure that there is enough power to support the operation of the APP during the recording. At the same time, the APP should be set to the locked state to prevent accidental exit and avoid incomplete recording data or data corruption.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 7.4.2. Charge a) b) c) Use a Micro USB cable to connect the charging box to a USB interface power source (need to be equipped on your own). Place the device into the charging box, and the device will automatically be attached. Here the device indicator is breathing yellow, indicating that the device is charging; green always on, indicating that charging is complete.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 terminal device. Make sure the Bluetooth function of the device is enabled. In the app, tap sleep recorder Connection, find the device by SN in the list and tap to connect. After connection, the EEG and other device information will be displayed. b） Increase patient information: In the main screen, enter patient management section, tap Add New Patient, and generate the patient information record.
Forehead Sleep Recorder buckle the body: 14 / 23 File No. DMR-SM902-4-25 Ver:A0 electrode sticker has fallen off and remains on the device. If so, use a suitable tool to remove the remaining male buckle. Check whether the metal of the female buckle on the equipment is fatigued and aged, and if so, contact the after-sales service. Copyright© Shenzhen BrainScience Bio-Info Technology Co.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 After the above problems are resolved, there are still problems that need to be handled, please contact the after-sales service unit. For contact details, please refer to “Customer Service” in Section 4 of this manual. The user or anyone without written authorization are not permitted to conduct any form of repair or other treatment on the product. 9.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 10.2. SpO2 and Pulse rate measurement performance 10.2.1. SpO2 measurement section (1) Measurement method Use a headband or medical headgear to fix the device and ensure that it is tightly worn by keeping proper pressure, with the user in a supine position. (2) SpO2 measurement range From 70%SpO2 to 100% SpO2. (3) SpO2 accuracy In the range of 70% ~ 100%, the measurement error of SpO2 ≤3 %. 10.2.2.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 return the product. 6) BSBT shall determine whether to repair or replace the Warranted Product; In the course of warranty service, BSBT may, but shall not be required to, make engineering improvements to the Warranted Product. 7) If BSBT reasonably determines that a repair or replacement is covered by the warranty, BSBT shall bear the costs of shipping the repaired or replaced product to User. All other shipping costs shall be paid by User.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 repositories may be moved to a separate data repository for use as set forth herein. User agrees that BSBT may use such De-identified Information for any purpose. User agrees that BSBT is the exclusive owner of the De-Identified Information. User licenses BSBT to store the data identified as PHI for the purposes of carrying out the operations as requested by User.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 Use of accessories other than those specified may result in increased equipment or system emissions or reduced immunity. Note: 1) 2) 3) 4) This equipment complies with the electromagnetic compatibility requirements of the IEC 60601-1-2: 2014 standard; Users should install and use this product according to the information related the electromagnetic compatibility prescribed in this manual.
Forehead Sleep Recorder File No.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 Table 9- Guidance and manufacturer's declaration - Electromagnetic immunity The forehead sleep recorder is intended use in the electromagnetic environment specified below, the consumer or user of the device should assure that it is used in such an electromagnetic environment.
Forehead Sleep Recorder c) File No. DMR-SM902-4-25 Ver:A0 electromagnetic sites should be considered. If it is measured that the field strength of the Forehead sleep recorder is higher than the applicable RF compliance level above, the Forehead sleep recorder should be observed to verify that it can work normally. If normal performance is not observed, supplementary measures may be necessary, such as reorienting or repositioning the Forehead sleep recorder.
Forehead Sleep Recorder File No. DMR-SM902-4-25 Ver:A0 guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver.
