We Care Wherever you are Electronic Stethoscope User’s Manual 006_User Manual 1／16
Contents Contents...................................................2 Introductio.................................................3 Safety Information.....................................3 EMC Compliance......................................9 Indications for Use/Intended Use ............5 Brief Introduction......................................5 Function Description.................................5 Chapter 01 Instructions for Use................12 Chapter 02 Product Specification.............
510(K) Response to Deficiency on K191667-S001 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.
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). If, in doubt, contact qualified technician or your local representative. 2.
10(K) Response to Deficiency on K191667-S001 5. When sending or sharing auscultation data, please pay attention to the protection of private data and ensure the facticity of the person. 6. When not using the application anymore, please delete the sensitive data stored in the idle or scrapped application device. Notice In order to reduce the risk associated with the environment, the stethoscope and battery should be properly disposed of or recycled in accordance with the local regulations.
510(K) Response to Deficiency on K191667-S001 Chapter 01 Instructions for Use 1.Turn on/off Manual Turn on: When the device is off, press the power button, OLED display will be activated, which indicates the device is on, and will enter the home interface. Manual Turn off: When the device is on, press the power button for two seconds, OLED display will shut off, which indicates the device is off. 2.
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. 5.
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. 8.2 Open the Application and registration. 8.
510(K) Response to Deficiency on K191667-S001 8.4 Connection with smartho-D2 Go back to the main interface and click ”Connect Core” to connect the device. After the connection is successful, it will automatically jump to the playback interface. The upper right corner of the playback interface will display the device power in real time.
510(K) Response to Deficiency on K191667-S001 Chapter 02 Product Specification ITEM Parameter Battery Specifications Battery Type 3.7V/2000mAh lithium ion polymer battery Battery Operation Time 60 Hours Battery Use-life 300 cycles Charging Time Technical Specifications 4 hours Binaural headset YES Chest-piece YES Sound processing Digital signal processor Display Screen 1.
510(K) Response to Deficiency on K191667-S001 Chapter 03 Maintenance and Warranty 1.Cleaning The stethoscope should be cleaned every time after use. Cleaning method: Under normal circumstances, it is not necessary to disassemble the stethoscope base and the upper cover for cleaning. The contact parts of the stethoscope outer casing are wiped clean with alcohol. Use the edge of the alcohol cotton swab to sliding wipe the myra, top cover, the outer casing and silicone rubber sleeve of the stethoscope.
510(K) Response to Deficiency on K191667-S001 3.Trouble Shooting No. Fault Type Occurrence Solutions 1 Battery Exhausted No response while press the on/off key. Charging the device 2 Poor Battery The battery indicator in the device is blank or the battery indicator in the APP is 0% Charging the device 3 Charging Problem The charging indicator icon is shown in the device Normal 4 Full Battery No charging indicator icon, device power off.
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.
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.
510(K) Response to Deficiency on K191667-S001 Recommended separation distances between portable and mobile 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.
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.
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.
