Introduction Thank you for chossing the Smartho-D2 Electronic Stethoscope. The Model Smartho-D2 brings you the very latest in advanced auscultation and wireless electronics technology in a highly ergonometric and easy-to-use format. Whether you are auscultating infant, pediatric or adult patients, in quiet or noisy environments, or picking up difficult-to-hear heart and body sounds, you’ll appreciate the technology that’s been built into this latest electronic...
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510(K) Response to Deficiency on K191667-S001 CAUTION Before using the device, please pay attention to and follow all safety & security instructions in these instructions, keep these instructions so that you can refer to them. Safety: 1.External equipment intended for connection to cable for charging, shall comply with relevant IEC standard (e.g.,IEC 60601 series for medical electrical equipment).
Brief Introduction The smartho-D2 Electronic stethoscope adopts acoustic sensor to convert the analog signal into a digital signal of auscultation, improve the quality of auscultation signal by increasing signal amplification to achieve the sounds described in the intended use section.
The battery information is displayed by the OLED frame, it is black if the battery is full, the blank in the battery grid indicates that there is no electricity, it needs to be charged in time. smartho-D2 electronic stethoscope use the...
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510(K) Response to Deficiency on K191667-S001 4.Mode Switch There are two kinds of auscultation modes (heart sound mode, lung sound mode), the switch of auscultation mode can be realized in two ways: 1) under the main interface, by pressing "return / mode key", the mode can be switched; 2) under the menu interface, the mode sub-menu can select the auscultation mode, and the current auscultation mode can be seen as the mode icon under the main interface.
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510(K) Response to Deficiency on K191667-S001 8. Data Storage and Review Please refer to the Application designated by the Mintti for data storage and review. The device cannot store any data without the Application. 8.1 Download the application named “Mintti” in the phone or other electronic device, and installed following the instructions in the phone.
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8.6 Data Review The data collected by smartho-D2 will be saved in real time on the mobile phone, and all the data can be reviewed under the “Local Record” on the “Setting”. Click on the data files to play back the historical data. During playback, drag the progress bar of the playback file to perform fast forward and backward operations.
This device is guaranteed for 12 months from the date of purchase. The smartho-D2 electronic stethoscope provides excellent service and warranty policies. If the product quality problems are found during the warranty period, except the detailed damage or accidental damage, the device will be repaired free of charge when it is returned to Mintti.
Appendix EMC Declarations Guidance and manufacturer´s declaration – electromagnetic emission The model smartho-D2 is intended for use in the electromagnetic environment specified below. The customer or the user of the model smartho-D2 should assure that it is used in such an environment.
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510(K) Response to Deficiency on K191667-S001 Guidance and manufacturer´s declaration – electromagnetic immunity The Model smartho-D2 are intended for use in the electromagnetic environment specified below. The customer or the user of the Model smartho-D2 should assure that it is used in such an environment.
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510(K) Response to Deficiency on K191667-S001 Guidance and manufacturer’s declaration – electromagnetic immunity The smartho-D2 is intended for use in the electromagnetic environment specified below. The customer or the user of the smartho-D2 should assure that it is used in such an environment.
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RF communications equipment and the model smartho-D2 The Model smartho-D2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model smartho-D2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model smartho-D2 as recommended below, according to the maximum output power of the communications equipment.
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510(K) Response to Deficiency on K191667-S001 Hefei Mintti Medical Technology Co., Ltd Address: C309, National University Science Park, 602 Huangshan Road, High-tech Zone, Hefei City, 230088, Anhui Province, China Contact: 86 0551-63638810 ■ Version:V 1.0 ■ P/N:D.H1.026 ■ Edition Date: 2018/11/01 Hefei Mintti Medical Technology Co., Ltd 006_User Manual 16/16...
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FCC Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
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