ExactVu Micro-Ultrasound Imaging System

Micro-Ultrasound System Brand Name Item: ExactVu Micro-Ultrasound Imaging System (120V)) with Single EV29L Transducer. 1) Essential/significant physical, functional, or performance characteristics.

ExactVu Micro-Ultrasound Imaging System: The ExactVu micro-ultrasound system provides a practical solution to perform targeted prostate biopsies within a standard urological workflow. Operating at up to 29 MHz, the ExactVu micro-ultrasound system enables a high level of resolution compared to conventional urological ultrasound systems.

1. Ultrasound must be able to operate high frequency up to 29MHz and a conventional frequency of (-3-12 MHz) transducers.

2. Must be able to do real-time guided biopsies 3. Electrical:

Voltage 110-120V 4. Environmental Operating Conditions: Temperature 10°C to 35°C (50°F to 104°F) Humidity 15% to 80% non-condensing Atmospheric Pressure 80kPa to 106 kPa 5. Environmental Storage Conditions: Temperature -20°C to 50°C (-4°F to 122°F) Relative Humidity 15% to 95% non-condensing Atmospheric Pressure 50kPa to 106 kPa 6. System Dimensions and Weight: Height (Retracted/Fully Extended) 136cm / 162 cm (53.5” / 63.8”) Width x Depth 54cm x 88cm (21.3” x 34.6”) Weight 150kg (330lb)

7. Connectivity: 3x USB 2.0 2x USB 3.0 1x Ethernet RJ45 1x HDMI out Purpose – ExactVu is to be use by our trained Urologist and Clinicians in our SCI Urology clinic, this equipment will allow or Urologist to targeted prostate biopsies in real-time.

2) Complete generic identification: Micro-Ultrasound System 3) Applicable model/make/catalog number – ExactVu 251033 4) Manufacturer name – ExactVu 5) Warranty- Warranty is 12 months following installation of the Equipment; provided that it shall continue to apply to defects, if any, of which Buyer has given written notice to EDAP within such 12-month period but were not corrected by the end of such 12-month period.

Per VAAR 811.104 and 811.105, I certify the following regarding the above information: The salient characteristics listed above are essential to the Government’s requirements.