6515--Titan Impedance Modules

ustomer s site. The authorization requirements do not apply and a security accreditation package is not required. The purchase is a one time buy; brand name Titan system IMP440. 2. Equipment Requirements The vendor shall furnish a new Interacoustics Titan system with IMP440 Impedance Module (or equivalent Titan configuration that fully meets or exceeds all requirements below): Titan handheld unit with IMP440 diagnostic/clinical impedance module, capable of: 226 Hz tympanometry, with automatic and manual operation and user programmable start/stop pressures. Ipsilateral and contralateral acoustic reflex testing with single intensity and reflex growth options. Reflex decay and reflex latency testing. Eustachian tube function tests for intact, perforated, and patulous eardrum (ET 1, ET 2, ET 3). Probe system and accessories appropriate for impedance testing, including: Basic probe with probe extension cable and ear tip kit (multiple sizes). Test cavities (at minimum 0.2, 0.5, 2.0, and 5.0 cc). Power and connectivity: Charging stand/cradle and external power supply. Two rechargeable lithium batteries (or equivalent) for handheld operation. Software: Titan PC Suite with IMP440 module, capable of handheld or PC controlled testing, protocol customization, data storage, and PC printing. Transducers: At minimum, contralateral phone/headset suitable for acoustic reflex testing (e.g., TDH or insert type transducer as specified by manufacturer). Optional features the vendor may propose (identify if included or priced separately): High frequency probe tones (678, 800, and/or 1000 Hz). Wideband tympanometry and/or wideband absorbance options on the Titan platform. All equipment must be new, current production, and fully compliant with applicable medical device standards (e.g., IEC 60601 1 and IEC 60645 series) as specified in the manufacturer s technical documentation. 3. Services to be Provided The vendor (contractor) shall provide the following services at a minimum: Delivery and Installation Ship equipment via FOB Destination Shipping address: Harry S. Truman VA Hospital 800 Hospital Dr. Columbia, MO 65201 Shipping date: 30 Days ARO Warranty and Support Information Provide and document all applicable manufacturer equipment warranties. Provide operator manuals and manufacturer instructions for use in electronic or printed form. 4. Contractor Responsibilities The vendor/contractor shall: Ensure that the equipment is operational in accordance with the manufacturer s electromagnetic compatibility and safety guidance. 5. Deliverables At the conclusion of installation and training, the vendor shall provide: (3) Titan PC Suite, 3 transducers, 3 probe extension cables, 3 charging stations, 6 rechargable lithium batteries, 3 eartip kits, 3 test cavities, 3 USB cables, 3 carrying cases. Product number: 8016169 Copies (electronic or hard copy) of: Manufacturer s Instructions for Use and technical information. Warranty documentation