36C26118Q9504-001.pdf

Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0

Brand Name Item: 3D Ultrasound Bladder Scanner

1) Essential/significant physical, functional, or performance characteristics.

Automatic 3D Ultrasound bladder scanner for non-invasive measurement of post-void residual bladder volumes

Procedure Type: Automatic 3D Bladder Scan Monitor Type: LCD Color Touchscreen Monitor Size: 6.4 in Printer: Thermal Battery Capacity: Up to 4 Hours Continuous Operation PC Connectivity: USB Dimensions: 14 cm x 32.5 cm x 15.5 cm (5.5 in x 13 in x 6 in) Weight: 2 kg (4 lbs.)

Evaluation criteria:

• Product is consistently easy to operate

• Product meets clinical needs

• Product scans accurately

• Patient seems comfortable with product

• Product training is easily understandable

• I would recommend this product

2) Complete generic identification – Portable Bladder Scanner

3) Applicable model/make/catalog number – PORTASCAN 3D Bladder scanner with thermal printer (5053A0011)

4) Manufacturer name – Laborie Portascan 3D

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.

• To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.

Name: Maria Salma Ubaldo RN

Attachment 1

Brand Name or Equal Worksheet (“Salient Characteristics”) v 2.0

Date: June 25, 2018