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r07a Screening Portable Audiometer

r07a Screening Portable Audiometer

Product catalog summary
General Specifications
The screening portable audiometer has dimensions of 240x190x30 mm and a net weight of 600 grams without the battery. It is housed in a plastic cabinet.

Test Types
It supports Pure Tone Audiometry and Automatic Audiometry, patient-controlled, compliant with ISO 8253-1 and the Hughson Westlake procedure. It is classified as Audiometer Class 4 according to EN ISO 60645-1.

Talk Forward
Features a built-in talk forward microphone with adjustable levels between 50-110 dBSPL.

Store Function
Includes a dedicated store button for saving measurements for up to 50 patients, identifiable by an ID number. Data can be viewed on the display or transferred to a PC using MDS software.

PC Interface
Utilizes MDS (Management Data Transfer) by RESONANCE for reporting and printing.

Standard Accessories
Comes with an R07A Audiometer, HB-7 Audiometric headband with DD45 transducers, patient pushbutton, 100 audiogram charts, pens, carrying bag, multilingual CE operation manual, and MDS software.

Optional Accessories
Includes insert phones, HB-7 headband with TDH39 transducers, medical CE approved external power supply, and ADC Audiocups Noise Excluders.

Power and Environmental Specifications
Operates on 4 AA batteries with automatic battery off switching and a battery status indicator. An optional external power supply is available. Operating conditions range from -20°C to +50°C for storage and +15°C to +35°C for operation, with humidity up to 90% non-condensing.

Range and Inputs/Outputs
Frequency range is 125 - 8000 Hz for both DD45 and insert phones. Inputs include tone and warble tone, while outputs are left and right AC conduction only.

Tone Presentation
Can be manual or reverse, pulsed at 0.5, 1, or 2 Hz, or continuous.

Audiometry Operating Specifications
Frequencies range from 125 Hz to 8000 Hz with varying intensity levels. Level steps can be set at 1, 2, or 5 dB. Distortion is typically 0.3%, below 1% at full intensity, with rise/fall times of 40 msec.

Compliance and Regulatory Standards
The device is manufactured under ISO 13485 and ISO 9001 certified quality systems and carries medical CE marks. It meets EN60645-1 type 4, ANSI 3.6, EN 60601-1, Class II, type BF, and EMC: EN 60601-1-2 standards.
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Catalog excerpts

r07a Screening Portable Audiometer-1

SCREENING PORTABLE AUDIOMETER PRODUCT SPECIFICATIONS GENERAL SPECIFICATIONS DIMENSIONS AND WEIGHT • L x W x H: 240x190x30 mm • Net Weight: 600 gr. without battery • Body material: Plastic cabinet TEST TYPES Pure Tone Audiometry, Automatic Audiometry Patient controlled, according to ISO 8253-1 and standard Hughson Westlake procedure (selectable on control panel) Audiometer Class 4 according to EN ISO 60645-1 TALK FORWARD Built-in talk forward microphone 50-110 dBSPL (adjustable on control panel) STORE FUNCTION • Dedicated Store button that enable to store measurements into the internal memory (up to 50 patients). The patient will be identified by an ID. number. • Stored data can be viewed on the built-in display or transferred to the PC using MDS software. • MDS (Management Data Transfer) by RESONANCE with reporting and printing features. AUDIOMETRY OPERATING SPECIFICATIONS RANGE • Frequency range (AC): 125 - 8000 Hz (DD45) 125 - 8000 Hz (Insert Phones) • Tone • Warble Tone +/- 5%, 5Hz (true sine wave frequency modulation) • Left and Right • AC Conduction only TONE PRESENTATION • Manual or Reverse (selected on Setup Menù) • Pulsed at 0.5,1 or 2Hz - (selected on Setup Menù) or Continuos All the frequencies can be enabled or disabled by the Setup menu except 1000 Hz. LEVEL STEPS 1,2 or 5 dB (selected on Setup Menù) QUALITY SYSTEM Manufactured, designed, developed and marketed under an ISO 13485, ISO 9001 certified quality system. Medical CE marks. COMPLIANCE/REGULATORY STANDARDS Meets or exceeds EN60645-1 type 4 and ANSI 3.6 Safety standard: EN 60601-1, Class II, type BF EMC: EN 60601-1-2 STANDARD ACCESSORIES • R07A Audiometer • HB-7 Audiometric headband with DD45 transducers • Patient pushbutton • 100 Audiogram charts • Blue and Red Pen • Carrying bag • Multilingual CE Operation Manual • MDS Software • Insert phones • HB-7 Audiometric headband with TDH39 transducers • Medical CE approved external power supply • ADC Audiocups Noise Excluders • 0.3% typical • below 1% at full intensity RISE/FALL TIMES 4 AA size Automatic battery off switching (battery save mode activated after 1, 2 , 5 minutes on non-activity or never) Battery status indicator on the display header Protection against test execution with a critical battery level. EXTERNAL POWER SUPPLY (OPTIONAL) Dedicated Medical approved power supply 100-240VAC 50/60Hz, 0.3A (input) +5VDC, 2A (output) ENVIRONMENTAL OPERATING ENVIRONMENT • Storage: -20° C up to +50° C • Operating: +15° C up to +35° C • Humidity: up to 90%, (non condensing) • Ambient pressure: from 700hPa up to 1060hPa Please contact Resonance should you have any questions: [email protected] The information, pictures and specifications found in this datasheet are intended as a general guideline for customers seeking information about supplies for Resonance equipment. Resonance makes no warranty, nor assumes any legal liability or responsibility for the accuracy, typing errors or mistakes, correctness or completeness of any information in this datasheet. The information in this datash

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