Salient Characteristics (SSN).pdf

Salient Characteristics

Aspirator, Surgical, Liposuction

Scope: The Department of Plastic Surgery Department at William Beaumont Army Medical Center (WBAMC) requires one Aspirator, Surgical, Liposuction System with Installation Training. The Liposuction System is needed for medical readiness for Active-Duty soldiers with symptomatic macromastia. Symptomatic macromastia interferes with soldiers' ability to wear body armor and perform military duties.

1. Essential Characteristics:

a. Seller must provide system that has been approved by the Food and Drug Administration (FDA) and must not have any unresolved FDA recalls

b. Seller shall provide the most current system

c. Shall have an ergonomic design for ease of use

d. Shall have a single integrated system for efficient use in the OR.

e. Shall have the ability to infiltrate tumescent fluid, containing small gas bubbles 5 to 10 microns in size, throughout the targeted fat tissue

f. Shall have the ability to produce acoustic energy delivered through an ultrasonic probe resulting in rapid formation and collapse of bubbles in the tumescent fluid, dislodging clusters of fat cells with minimal impact on vessels, nerves and other tissues (fat emulsification)

g. Shall have the ability to remove mixed fat cell and tumescent fluid through a small-diameter cannula thereby reducing trauma to vessels, nerves and fibrous tissue matrix

h. Shall have solid grooved ultrasonic probes

i. Shall generate ultrasonic operating frequency of 36 kHz

j. Shall have an Infiltration and Aspiration console that is efficient in removal of fatty tissue with precise suction pressure control to preserve fat cell viability

k. Shall have an ultrasonic amplifier with the ability to generate both continuous and pulsed wave energy and a display to track activation time

l. Shall have a replaceable suction filter for trapping any overflowing fat/fluids

m. Shall have a digital readout for precise tracking of fluid. Measures infiltrate volume up to 4500 mL

n. Shall have an attachment of up to four 1,250 mL collection cannister

o. Shall have a peristaltic infiltration pump that delivers smooth infiltration, which is adjustable and reversible

p. Shall have a wireless footswitch for untethered positioning and easy control over infiltration and ultrasound activation

q. Seller shall provide two copies of operator/user manual.

r. Seller must be an authorized dealer, distributor, or reseller for the proposed system.

s. Seller must provide a warranty for the system in accordance with Original Equipment Manufacturer (OEM).

2. Training:

a. Onsite clinical staff training at William Beaumont Army Medical Center and morning and afternoon classes shall be conducted at the prescribed date and time. Upon completion of training, the contractor shall provide a signed attendance roster.

b. Onsite training for two clinical engineers and clinic Staff.

3. Installation:

a. Seller shall contact the Healthcare Technology Management section at 915-XXX-XXXX to arrange for installation of system five business days from award of contract. The installer shall be an authorized Original Equipment Manufacturer (OEM). Installer is responsible for providing the tools, equipment, and material required to complete installation, removal and disposal of all trash and material in site identified disposal containers.

b. Post access: To gain post access employee/installer of company must provide signed memorandum on company letterhead as to their reason for required access with proper identification at the Chaffee Visitor Control Center, building 2616, 2527 Chaffee Rd., Ft.

Bliss Texas 79918, Monday through Fridays (closed Federal Holidays) and Buffalo Soldier Visitor Control Center, Building 5400, Ft. Bliss, Texas 79918 on weekends.

c. Hospital Access: Installers must check-in at the WBAMC Provost Marshall Office, building 18511 Highlander Medic St, El Paso, Texas 79918, 1st Floor, room HB1717, Monday through Friday 07:30 to 15:30 (closed Federal Holidays).

d. Safety: Will be required to obtain safety briefs from the WBAMC Safety Office. Must provide a copy of company safety program.

4. Delivery Requirements:

a. Delivery of equipment no later than 60 calendar days from award of contract.

b. The seller shall ensure the package is appropriately marked with the contract number, delivery address, and contracting officer representative information - no partial delivery is authorized. Shall notify contracting officer representative three business days before delivery to include providing tracking information.

c. Delivery during business hours of 08:00 to 15:00hrs MST, Monday through Friday except Federal Holidays.

d. Seller is responsible for providing proper tools and equipment for offloading and inside delivery to required location.