FDA
1 /5Pages

FDA

FDA
1 /5Pages

Catalog excerpts

FDA-1

PURE TONE CLINICAL AUDIOMETER hearTest is a world-first certified digital audiometry solution that uses a tablet linked to a cloud data management platform for comprehensive audiometry.

 Open the catalog to page 1
FDA-2

COMPLIES TO INTERNATIONAL STANDARDS . . . . IEC 60645-1 - Equipment for pure tone audiometry (type 4 audiometer) ANSI S3.6 - Specification for audiometers (type 4 audiometer) ISO 8253-1 - Pure tone air conduction audiometric test methods ISO 389 series - Reference zero for the calibration of audiometric equipment United States of America South Africa UNITED STATES (FDA COMPLIANT) BENEFITS & FEATURES CLINICALLY VALID TESTS AUDIOGRAM RESULT ENVIRONMENTAL NOISE WARNING Evidence-based, validated audiometer calibrated to ISO/ANSI/SANS standards. Audiogram with pure tone average and degree of loss classification....

 Open the catalog to page 2
FDA-3

HARDWARE DIAGNOSTIC HARDWARE SET A Test down to 10 dB HL Samsung Tab A, Sennheiser HD 280 Pro headphones & carry case DIAGNOSTIC HARDWARE SET B Test down to -10 dB HL Samsung Tab A, Sennheiser HD 280 Pro headphones, v3 DAC & carry case DIAGNOSTIC HARDWARE SET C Test down to -10 dB HL Samsung Tab A, RadioEar DD450 headphones, v3 DAC & carry case PROTOCOLS Frequency range Testing protocol Custom protocol setup possible Default protocol (500, 1,000, 2,000, 4,000, 8,000 Hz) Daily check protocol (500, 1,000, 2,000, 4,000, 8,000 Hz) Threshold seeking methods Shortened Ascending (ISO 8253-1:2010) Intelligent...

 Open the catalog to page 3
FDA-4

TECHNICAL SPECIFICATIONS AND PERFORMANCE Carry case dimensions • Includes a handle • Includes a shoulder strap Net weight (contents: tablet, headphones, and charger) Safety and design standards Medical device class Degree of protection (electric shock) Type B applied part Protection against ingress (IP): • Tablet • Headphones Usage environment Professional healthcare environment Operating temperature Humidity Ambient pressure 35 cm x 26 cm x 12 cm 13.77 inch x 10.23 inch x 4.72 inch TONE SPECIFICATIONS Type Pure tone with optional masking Rise / fall time 35 ms (-20 dBFS to -1 dBFS and vice versa)...

 Open the catalog to page 4
FDA-5

*Referenced to 0 dB HL testing from 500 Hz and up *Referenced to 0 dB HL testing from 500 Hz and up

 Open the catalog to page 5

All HearX Group catalogs and technical brochures

  1. hearScope

    2  Pages

  2. hearTest

    5  Pages

  3. hear Screen

    2  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.