Audiometer Specs.pdf

The portable screening audimeter has dimensions of 240 x 190 x 30 mm and weighs 600 gr without battery, with a plastic cabinet body. It performs pure tone audiometry and automatic audiometry, meeting IEC 60645-1 type 4 and ANSI 3.6 standards. The device has a built-in talk forward microphone, store function for up to 50 patients, and PC interface with MDS software. Standard accessories include an audiometric headband, patient pushbutton, and multilingual operation manual. The device operates on 4 AA batteries with automatic battery off switching and has an optional medical CE approved external power supply. It meets safety standards IEC 60601-1 3rd edition, Class II, type BF, and EMC IEC 60601-1-2. The frequency range is 125-8000 Hz, with tone presentation options and level steps of 1, 2, or 5 dB. The device is manufactured under an ISO 13485 and ISO 9001 certified quality system, with medical CE marks and FDA approval.