Download Otoacoustic Emission (Screening unit) OAE (DP and TE)

Otoacoustic Emission (Screening unit) OAE (DP and TE)
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Purchaser’s Specifications
Otoacoustic Emission (Screening unit) OAE (DP and TE)
Manufacturer
Brand
Type / Model
Country of Origin
Description of Function
OAE hearing screener is used to precisely and objectively screen for hearing loss and to
determine cochlear status in new born, infants, toddlers, children & adult.
Operational Requirements
It shall be portable and battery operated device.
System Configuration
Otoacoustic Emission (Screening unit) OAE (DP and TE), complete unit with complete
accessories.
Technical Specifications
Hearing screener for measurement of OAE by DPOAE and TEOAE tests
It shall be hand held, lightweight unit.
It shall perform fast automatic tests.
Screener should be integrated with evoked otoacoustic emissions (OAE) and auditory brainstem
responses (ABR) into a single, portable screening device.
The device shall be self- contained with diagnostic features, to test new born, children, adults, the
elderly and all difficult- to- test patients.
TEOAE (Transient Evoked Otoacoustic Emission):
 Frequencies: approx. 1.5 to 4 kHz
 Sample rate: 16 kHz
 Stimulus level: ca. 80 dB SPL peak
 Stimulus type: Nonlinear click
 Statistical stop criterion (TE Quick) or user defined
 Stop criterion (SNR: 3, 6 or 9 dB) in 3, 4, or 5 out of frequency bands (1.5, 2, 3, 4 kHz)
(TE diagnostic.)
 Window of analysis: 5-13 ms post stimulus.
DPOAE (Distortion Product Otoacoustic Emission):
 Frequencies: 2 to 5 kHz
 Sample Rate - 24kHz
 Frequency ratio f2/f1: 1.2
 Level ratio L2/L1: Scissor Paradigm
 Measurement Interval- 512 samples
 Frequencies f2: 2, 3, 4, 5, kHz (single & multiple selections possible)
 Stimulus level L2: 35 to 65 dB HL (in steps of 5dB)
Stimulus intensity: 40 to 70 dB SPL (DPOAE). 83 dB SPL (TEOAE).
Maximum output (Protection): 90 dB SPL.
Microphone system noise:
 -20 dB SPL @ 2 kHz (1 Hz bandwidth).
 -13 dB SPL @ 1 kHz (1 Hz bandwidth).
It shall have multiple test methods.
It shall have data storage memory for 250-300 tests.
It shall have facility for data transfer to PC via USB or wireless
Shall have facility to print data through thermal printer as well as through external printer.
Display: LCD or LED type.
It shall come with measuring probe, AC adaptor for battery charger, power cord, and screening
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Purchaser’s Specifications
software.
It shall operate on integrated Lithium-ion rechargeable battery with long hours of operation.
Bidder to specify the duration of hours of battery operation.
Accessories, spares and consumables
Accessories:
 Electrodes: 2 each
 Disposable electrodes: minimum 4 Packets.
 Thermal printer: 01 no.
 Thermal printer roll: 5 set
 Infant ear tip kit: 5 sizes
 Universal ear tips: 100 nos.
 Child ear tip kit: 01 no.
 Adult ear tip kit: 01 no.
 Comfort cops.
 Probe cleaning kit: 01 no.
 Carrying case: 01 no.
All standard accessories, consumables and parts required to operate the equipment, including all
standard tools and cleaning and lubrication materials, to be included in the offer. Bidders must
specify the quantity of every item included in their offer (including items not specified above).
Operating Environment
The system offered shall be designed to operate normally under the conditions of the purchaser's
country. The conditions include Power Supply, Climate, Temperature, Humidity, etc.
Power supply: Shall operate on integrated Li-ion battery.
Standards and Safety Requirements
Must submit ISO13485:2003/AC:2007 for Medical Devices AND
CE (93/42 EEC Directives) or USFDA approved product certificate.
User Training
Must provide user training (including how to use and maintain the equipment).
Warranty
Comprehensive warranty for 2 years after acceptance.
Maintenance Service During Warranty Period
During the warranty period supplier must ensure with corrective/breakdown maintenance
whenever required.
Installation and Commissioning
The bidder must arrange for the equipment to be installed and commissioned by certified or
qualified personnel; any prerequisites for installation to be communicated to the purchaser in
advance, in detail.
Documentation
User (Operating) manual in English
Service (Technical / Maintenance) manual in English
List of important spare parts and accessories with their part number and costing.
Certificate of calibration and inspection from factory.