Intended Use The N9+ (OTC) device, combined with a smartphone application (Nonagon Care Kit), is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound, body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined...

Proper care, cleaning, and handling are essential for the operation of the Nonagon Care Kit. Follow the instructions below for cleaning and disinfection of the kit. Warnings Cautions Cleaning Ear specula and tongue depressor: Note: Never use thinners, benzene, gasoline or other strong solvents to...

N9+ Device N9+ Wireless Otoscope Calibration The N9+ system is initially calibrated at the time of manufacture. If this system is used according to the use instructions, periodic readjustment is not required.Note: A functional tester cannot be used to assess the accuracy of the Pulse...

Software Requirements The N9+ device can be used with any smartphone within the range below: Model and operating system Android: 8.1 and up. Minimum 4GB RAM.iPhone: 8 and up, iOS 11.0 and up. Minimum 2GB RAM. Back Camera Still images of at least 4Mpixels. Incompatible...

By using the Nonagon N9+ Device (the “Product”), you are accepting the Product’s warranty terms set out below. Therefore, please read these terms carefully. Warranty Nonagon Ltd. (the “Nonagon”) warrants your new Product against defects in materials and workmanship for the applicable Warranty Period:“Warranty Period”...

SpO2 Accuracy Graphical plot Electromagnetic Emissions-for all Equipment and Systems Guidance and manufacture’s declaration-electromagnetic emission: The Nonagon device is intended for use in the electromagnetic environment specified below. The user of the device should assure that it is used in such an environment. Electromagnetic Immunity-for...