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MB 11

MB 11

MB 11

Product catalog summary
Overview
The MAICO MB 11 BERAphone® is a device designed for fast and efficient newborn hearing screening using automated Auditory Brainstem Response (ABR) testing. It integrates a speaker, electronics, and measuring electrodes into a single unit, enhancing comfort and efficiency.

Key Specifications
  • Fast and Baby-friendly Screening: The device provides quick results, detecting responses at 35 dB nHL to determine a PASS result.
  • CE-Chirp® Technology: This patented technology stimulates all cochlea regions simultaneously, yielding higher responses and faster results even in noisy environments.
  • Features: Includes automatic impedance checks, USB connectivity for power and data transfer, and the ability to export patient data.

Technical Data
  • Dimensions and Weight: BERAphone® - 120 mm x 93 mm x 30 mm, 142 g; Cradle - 119 mm x 160 mm x 74 mm, 270 g.
  • Display: Shows test results, signal quality, and impedance test status.
  • Languages Supported: English, German, Spanish, French, Italian, Dutch, Turkish, Hungarian, Russian, Chinese, Japanese.
  • Power Supply: USB-Port 5V DC max. 400 mA.
  • ABR Stimuli: CE-Chirp® with a stimulus rate of ~90/s and level of 35 dB nHL.
  • Test Duration: Ranges from 16 to 180 seconds.

Computer Requirements
  • Processor: 2 GHz or more.
  • RAM: Minimum 1 GB.
  • Hard Disk: Minimum 10 GB free space.
  • Interface: USB 1.1, 2.0, or 3.0.
  • Display: Minimum resolution of 1280 x 1024.
  • Operating System: Windows 7, 8, or 10 (32/64-bit Pro).

Standards and Safety
  • ABR: IEC 60645-7, Type 2.
  • Safety: IEC 60601-1, Type BF.
  • EMC: IEC 60601-1-2.
  • CE Certification: According to Medical Device Regulation (EU) 2017/745, Class IIa.

Components
  • Standard: Includes MB 11 Box with BERAphone®, cradle, replacement electrodes, electrode gel, carrying case, PC software, and USB cable.
  • Optional: Label printer.

Recommendations
For optimal test results, the use of Sanibel disposables is recommended.
See more

Catalog excerpts

MB 11-1

MB 11 BERAphone® Excellence in Newborn Hearing Screening Fast and Baby-friendly screening The MAICO MB  BERAphone offers a fast automated 11 ABR screening test for newborns. The patented BERAphone® includes speaker, electronics and measuring electrodes in one unit. The cushioned earpiece and the reusable electrodes allow testing without adhesive disposables, thus making it more comfortable for the baby. If a response at 35 dB nHL is detected and verified, the test result is PASS. • Fast and automated ABR-screening, reliable results within seconds • Unique BERAphone® with integrated electrodes saves costs for disposables • Automatic impedance check ensuring precise and clear signal conditions • Export patient details and test data for tracking purposes • Stimulation level at 35 dB nHL • USB connection for power supply and data transfer The patented CE-Chirp® The CE-Chirp® stimulates all regions of the chochlea at the same time and thus generates much higher responses and faster results than a standard click. This leads to very reliable results under normal noisy condition

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MB 11-2

Technical Data Computer Requirements MB 11 BERAphone® Dimensions / Weight Test result (Pass, Refer or Abort), test diagram with line towards PASS, signal quality or EEG, Hard Disk Minimum 10 GB free disk space traffic light for impedance test English, German, Spanish, French, Italian, Dutch (Belgium), Turkish, Hungarian, Russian, Graphic card Direct X9 with WDDM 1.0 or higher Chinese, Japanese Operating System Power supply Dimensions / Weight according to Medical Device Regulation (EU) 2017/745, Class IIa 3 reusable stainless-steel electrodes Standard Components Integrated dynamic speaker (8...

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*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.