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Otoacoustic Emission (Screening unit) OAE (DP and TE) S.N. 1 1.1 2 2.1 3 3.1 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 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 S.N. 4.17 5 5.1 6 6.1 6.2 7 7.1 7.2 8 8.1 9 9.1 10 10.1 11 11.1 12 12.1 12.2 12.3 12.4 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.