Synopsis.pdf

The Defense Logistics Agency Troop Support Medical Supply Chain (DLA) plans on issuing solicitation SPE2D1-23-R-0001 to procure Negative Pressure Wound Therapy Systems.

This solicitation provides for the supply of negative pressure wound therapy systems and related supplies/accessories. The minimum requirements of the schedule of supplies is described in the below table:

SRD# DESCRIPTION OF

MINIMUM

REQUIREMENT

AND/OR

OBJECTIVE

MINIMUM REQUIREMENT OBJECTIVE

1 FDA Clearance YES N/A 2 Aircraft Use Vendor agrees to pass Joint Enroute

Care Equipment Test Standard (JECETS) prior to delivery of any additional units outside the ones required for testing.

Vendor shall provide any successful results, documentation or certification of other aircraft testing completed. For instance, documentation of usage by foreign militaries aircraft, FAA, or commercial flight certification showing passing results.

3 Modes The device controls shall consist, at a minimum, of:

Modes (off/continuous/intermittent), Intermittent On Time Intermittent Off Time Vacuum Adjust Control Safety Lockout

N/A

There

Pressure Range The negative pressure shall be adjustable and include at least -50 to -150 mm Hg pressure range

The negative pressure shall be adjustable, and the range shall be at least -25 to -200 mm Hg.

The interval between pressures adjustments shall be no greater than 25 mm Hg.

5 Operations Device must be operational while secured vertically and horizontally with accessibility of controls

N/A

6 Display The Device shall have visual and audible alarms with the ability to silence active alarms and all-alarm suspension. Consider limitations due to aircraft ambient noise degrading effectiveness of audio alarms.

Shall provide audible and visual alarms in least 2 colors (Ex. high and routine priority) depending on the type of alarm.

REQUIREMENT

AND/OR

OBJECTIVE

MINIMUM REQUIREMENT OBJECTIVE

7 Device display shall be digital and readable in low-light environments and Night Vision Goggle compatible

N/A

8 Carrying Bag The device shall have a carrying bag.

9 The carrying bag with the device inside shall be able to be carried with one hand using a handle or strap.

N/A

10 The device and carrying bag together shall weigh equal to or less than 5lbs (2.3 Kg)

The device and carrying bag together shall weigh equal to or less than 3lbs (1.4 Kg)

11 Portability and Mounting

Shall have a portable configuration, with the ability to be mounted onto an IV pole or rail. Shall have the ability to be secured to a standard NATO litter and Medical Equipment Rail Kit

(MERK).

While contained in the carrying bag, the device shall be portable with the ability to be mounted onto an IV pole or rail.

While contained in the carrying bag, the device shall have the ability to be secured to a standard NATO litter and Medical Equipment Rail Kit

(MERK).

12 Device must have some capability to secure if not mounted (i.e., handle or tie down point).

N/A

13 Infection Control Device must be able to be cleaned and disinfected in accordance with infection control guidance per AFI 44- 108 Infection Control Program (Attachment 3)

N/A

14 Back Flow Prevention

Device must have back flow prevention N/A

15 Collection canisters

Device shall have at least one canister of, at least 200ml in size, and all accessories required to connect the canister to the device itself.

Device shall have two or more canisters of, at least 200ml in size, and all accessories required to connect the canister to the device itself.

16 Canister shall be disposable, constructed from clear, non-breakable material and have an integral check valve to prevent leakage

Canister shall include a solidifying agent.

REQUIREMENT

AND/OR

OBJECTIVE

MINIMUM REQUIREMENT OBJECTIVE

17 Dressings The system shall either be A) a single channel device with the ability to split the pressures into at least 2 wound locations simultaneously or B) shall be a multi-channel device with the capability to both treat a single wound site or pressurize at least 2 wound locations simultaneously. The vendor shall specify how this is accomplished (i.e., via two separate dressings or a single dressing with multiple pressure points).

N/A

18 Shall have the capability to use foam or gauze dressing.

Shall have the capability to use foam and gauze dressing.

Shall have the capability for instillation.

The gauze or foam dressing shall not be proprietary

19 Power Source Shall operate from 110~240 VAC, 50/60 Hz, and a replaceable battery.

Shall operate from 110-240 VAC, 50/60/400 Hz and 12-28 VDC, and a replaceable battery.

20 Shall be capable of operating from any of the specified external AC or DC power sources while the internal battery is being recharged.

Simultaneous operation and recharge shall not affect recharge time.

Automatic switching between these power sources required

N/A

21 Battery Device must run continuously on battery power on a single charge on max suction for at least 6 hours.

Device must run continuously on battery power on a single charge on max suction for at least 12 hours.

22 Device must fully charge (> = 90 %) a depleted battery in 8 hours

Device must fully charge (> = 90 %) a depleted battery in 6 hours

23 Device must display battery capacity N/A

24 Device must have battery shelf Life of at least 2 years

Device must have battery shelf life of at least 4 years

REQUIREMENT

AND/OR

OBJECTIVE

MINIMUM REQUIREMENT OBJECTIVE

25 Battery must be replaceable by a

BMET

That battery shall be hot swappable by the user

26 Device must include an extra battery N/A 27 Training Vendor shall provide 1 initial training for the user and 1 refresher user training.

N/A

28 Vendor shall provide distance learning user training for the full system to include all components and accessories.

N/A

29 Vendor shall provide training materials for users and maintenance on new functionality and enhancements.

N/A

30 Manuals Each device shall include 1 hard copy operator/user manual. Each delivery order will also include 1 digital equivalent manual.

Each device shall include 1 hard copy service manual. 1 digital equivalent service manual will be sent to AFMRA.

The service manual will include theory of operation, trouble shooting, all maintenance and calibration requirements, illustrated parts breakdown with part numbers for each replaceable component, all applicable schematics [electronic, pneumatic, etc.]. Manuals will be the same as provided to OEM service engineers.

N/A

31 Warranty Shall include a year of warranty. The system has a warranty greater than one year

32 Supportability Shall support the device with parts, consumables, supplies, and software updates available and software updates for purchase to make repairs for 7 years from the date of the last unit sold.

Shall support the device with parts, consumables, supplies, and software updates available and software updates for purchase to make repairs for 8 years from the date of the last unit sold.

REQUIREMENT

AND/OR

OBJECTIVE

MINIMUM REQUIREMENT OBJECTIVE

33 Maintainability Vendor shall only quote items that can be maintained by the AF biomedical equipment technicians.

All work shall be performed by BMETs with no training required.

N/A

34 The Device shall be maintainable by military Biomedical Equipment Technicians (BMET) using standard tools (as provided in standard BMET kit; no special tools required) without voiding warranty. Repair parts and/or telephone consultation before and after warranty period will be provided to DoD BMETs without need to attend manufacture specific training or incurring additional telephone consultation costs. Any service keys required shall be provided to the AF or with no expectation to have a maintenance contract or BMET training.

N/A

35 Device system software updates

Device system software that may require modification during system life shall be upgradable in the field by military Biomedical Engineering Technicians using a computer interface, the Internet, or a CD supplied by the manufacturer without changing hardware components of the device. Manufacturer notification of product software modification and/or updates sold to customers is required.

Outdated software should not render the device unusable.

REQUIREMENT

AND/OR

OBJECTIVE

MINIMUM REQUIREMENT OBJECTIVE

36 Network Connectivity

Although no internet connectivity will be used while in deployed environment, if the device is capable of network connectivity.

Device must also be capable of disabling any networking ports or other communication ports, such as Wi-Fi or Bluetooth.

N/A

37 Operating System and Major

Components

If the device has an Operating System, the OS shall be maintained and supported for the at least 3 years.

All major component software applications (SQL, IIS, .Net, etc.) have current commercial support.

The resulting contract will be a Firm Fixed Price, Single Award Indefinite Delivery/Indefinite Quantity (IDIQ) contract for a five-year base term plus five one-year option periods.

Deliveries made under the contract will be F.O.B. Destination to CONUS locations.

Vendors may be asked to support OCONUS locations. For OCONUS locations; F.O.B. Destination pricing shall be established prior to order issuance to factor any additional shipping charges.

The Government reserves the right to issue orders on a F.O.B. Origin basis.

Delivery shall be made within 60 calendar days after date of delivery order (ADO) unless otherwise specified

The Estimated Dollar Value is $25,000,000.00. The Guaranteed Minimum number of units that will be purchased off of the resulting contract is 3 units. The contract Maximum Dollar Value is $75,000,000.00.

The Trade Agreements Act (TAA) will apply to this acquisition.

The solicitation will be issued on the basis of Full and Open competition and on an unrestricted basis.

The solicitation is estimated to be released on June 26, 2023 and close on July 26, 2023 1 p.m. EST.

A copy of the solicitation will be available via DLA Internet Bid Board System at https://www.dibbs.bsm.dla.mil/RFP on the issue date cited in the RFP.