M0030_Audiometer, Diagnostic_Redacted.pdf

Specifications (continued)

- Custom Configuration: Configurable tests and preferences to improve workflow and optimize speed of testing

- Special Tests: Pre-configured special tests such as QuickSIN, BKB-SIN, TEN (HL), ABLB, SISI and Tone Decay addresses the research trends in hearing evaluation

- Assistant Monitor: Allows direct communication between operator and assistant eliminating the need for an externalintercom system

- Word Lists: Integrated internal digital word lists provide effortless access to commonly used word lists providing consistent and reliable recorded speech testing

- Panel Navigation: Gold standard ergonomic design with familiar one-button, one-function front panel navigation

- Direct Print: Expedite the data entry and test administration

- Data Transfer: Electronic data is transferred with a single button press

PRODUCT SPECIFICATIONS

Dimensions and Weight

- W x D x H: 20.1 inches x 14.6 inches x 13.2 inches (LCD raised)

51.0 cm x 37.0 cm x 33.5 cm

- Height with LCD lowered – 5.5 inches (14.0 cm)

- Weight: 17 lb (7.7 kg)

- Shipping Weight: 27 lb (12.25 kg)

- Power Consumption: 90 Watts

Channels

- Two Independent Channels

Pure Tone – Channels 1 and 2 Frequency Range:

- Air Conduction: 125 Hz to 12,000*** Hz

- High Frequency:* 8,000 Hz to 20,000 Hz (8 kHz, 9 kHz, 10 kHz, 11.2 kHz, 12.5 kHz, 14 kHz, 16 kHz, 18 kHz*** and 20 kHz***)

- Full Frequency Range:* 125 Hz to 20,000 Hz

- Bone Conduction: 250 Hz to 8,000 Hz

- Sound Field:* 125 Hz to 8,000 Hz

- Paired Inserts:* 125 Hz to 8,000 Hz

- Frequency Accuracy: ±1%

- Total Harmonic Distortion:

< 2% (earphones and paired insert phones*) < 5% (bone vibrator)

Intensity Range:**

- Air Conduction (TDH 50P): -10 dB HL to 120 dB HL

- High Frequency:* -20 dB HL to 100 dB HL (with Sennheiser HDA 200 Phones)

- Bone Conduction

Mastoid: -10 dB HL to 75 dB HL Forehead: -10 dB HL to 65 dB HL

- Sound Field:* -10 dB HL to 90 dB HL (basic speakers) -10 dB HL to 96 dB HL (high performance speakers) -10 dB HL to 102 dB HL (high performance speakers and external booster amplifier)

- Paired Inserts:* -10 dB HL to 110 dB HL

- Masking Intensity Range (Calibrated in effective masking) Narrow Band Noise:

Maximum dB HL is 15 dB below tone White Noise:

Maximum dB HL is 30 dB below tone

Signal Format:

- Steady: Tone continuously present

- Pulsed: Tone pulsed 200 msec ON, 200 msec OFF

- FM: Modulation Rate: 5 Hz Modulation Depth: +/- 5%

- Pulsed/FM: Pulsed and Modulated

- Pediatric Noise

- Pediatric Noise Pulsed

Speech – Channels 1 and 2

- Microphone: For live voice testing and communications

- INT/EXT A & INT/EXT B: Can be utilized for internal wave files or recorded speech material from an external digital device

Intensity Range:

- Air Conduction: -10 dB HL to 100 dB HL for TDH 50P (Linear Type 4)

- Bone Conduction Mastoid: -10 dB HL to 55 dB HL Forehead: -10 dB HL to 35 dB HL

- Sound Field:* -10 dB HL to 80 dB HL

- Paired Inserts:* -10 dB HL to 95 dB HL

Masking Intensity Range:

Speech Noise:

- Air Conduction: -10 dB HL to 95 dB HL (TDH 50P) Bone Conduction:

-10 dB HL to 50 dB HL (mastoid) -10 dB HL to 35 dB HL (forehead) Sound Field: -10 dB HL to 80 dB HL

- White Noise:

Air Conduction: -10 dB HL to 95 dB HL (TDH 50P) Bone Conduction:

-10 dB HL to 50 dB HL (mastoid) -10 dB HL to 35 dB HL (forehead) Sound Field: -10 dB HL to 80 dB HL

Special Tests

- ABLB or Fowler: Tone alternating between Channel 1 and Channel 2: Channel 1 is 400 msec ON, 400 msec OFF followed by Channel 2, 400 msec ON, 400 msec OFF

- SISI: An intensity increment is added to a tone in the selected channel for 200 msec, every 5 seconds The HL increments are in 1, 2 or 5 dB

High Frequency:* Pure tone testing in the frequency range of 8,000 Hz to 20,000 Hz using circum-aural headphones

- TEN: TEN masking noise will be presented to the test ear. Pure tone stimuli between 500 Hz and 4000 Hz may be used at 1, 2, or 5 Db increments to obtain TEN thresholds

- QuickSIN: Six (6) sentences with five (5) key words per sentence are presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios. The SNR’s used are 25, 20, 15, 10, 5, and 0

- BKB-SIN: Contains 18 List Paris. The sentences are presented at prerecorded signal-to-noise ratios that decrease in 3-dB steps. Each list in the pair is individually scored, and the results of the two lists are averages to obtain the List Pair score. Results are compared to normative data to obtain the SNR Loss

PC Enabled/Stand Alone

- Transfer data to connected PC with an E-Record Solution Software

- Print complete report directly to a compatible USB printer

Special Tests (user defined)

- MLB

- Lombard test

- Pure Tone Stenger

- Speech Stenger

- SAL

- Doerfler - Stewart Test

Communications and Monitoring

- Talk Forward: Permits the tester to speak through the examiner microphone into the selected transducer

- Talk Back: Allows the examiner to listen to comments from the patient in the testing booth

- Monitor: The monitor headset or monitor speaker built into the instrument housing may be used by the examiner to listen to Channel 1, Channel 2, Aux intercom, and/or Talk Back signals

- Aux Intercom: The built-in Auxiliary Intercom and assistant headset allows the examiner to speak directly to an Assistant and allows the assistant to hear what is being presented to the patient

- On-Board VRA Control: The built-in VRA controls facilitate fast and simple activation of VRA systems

Optional Accessories

- Wireless keyboard and mouse

- Gooseneck microphone

Environmental Requirements

- Temperature: +15ºC to 40ºC (59 to 104ºF)

- Relative Humidity: 5% to 90% (non-condensing)

- Ambient Pressure Range: 98 kPa to 104 kPa

- Background Sound Level: <35 dB(A)

- Frequency of Use: Once a year to multiple times per day

- Storage Temperature: -20ºC to + 60ºC (-4ºF to 140ºF)

Quality System

- Manufactured, designed, developed and marketed under ISO 13485 certified quality systems

Compliance/Regulatory Standards Designed, tested and manufactured to meet the following domestic (USA), Canadian, European and International Standards:

- ANSI S3.6, ANSI S3.43, IEC 60645-1, IEC 60645-2, ISO 389

- UL 60601-1 American Standards for Medical Electrical Equipment

- IEC/EN 60601-1 International Standards for Medical Electrical Equipment

- CSA C22.2 # 601-1-M90

- Medical Device Directive (MDD) to comply with “EC Directive” 93/42/EEC

NOTE:

* Optional configuration ** The maximum HL values are applicable to the middle frequencies only *** Optional configuration