1.0 Product Overview: This document outlines the requirements for a small, lightweight, and durable multi-therapy infusion pump designed for use in pre-hospital, aeromedical, and military environments. The Office of the Command Surgeon is seeking a portable device that offers a wide range of therapeutic applications in a compact and rugged form factor, capable of reliable function in demanding field conditions. The intended use for this device is for intravascular, subcutaneous, intra-arterial, epidural, and perineural infusions administered by licensed military healthcare professionals in clinical, ambulatory, and medical transport settings (both air and ground).
2.0 Core Capabilities and Specifications: The primary requirements for the infusion pump are focused on size, weight, and cube (SWaP) to ensure it can be seamlessly integrated into already existing medical pack-outs and ruck sacks.
Feature Required Specification
- Dimensions Objective: Less than 6” x 4” x 2”
- Weight Less than 15 oz (excluding battery)
- Delivery Modes Must support: Continuous, Patient-Controlled Analgesia (PCA), Intermittent, Multi-Step, Total Parenteral (TPN), and Epidural infusions.
- Flow Rate 0.1 mL/h to 999 mL/h
- Flow Rate Accuracy ±2.5% under normal conditions
- Volume to be Infused 0.1 mL to 9,999 mL
- Drug Library Must support up to 40 clinical care areas and at least 1,000 drugs per area.
- Power Source AC: 100-240V, 50-60 Hz DC: Rechargeable Li-Ion battery
- Battery Life Minimum of 24 hours of continuous operation at a rate of 125 mL/h.
- Environmental Device must feature a touch screen that is fully operable when wet. The casing must be designed to withstand drops and fluid splashes.
- Operating Temperature +5°C to +40°C (41°F to 104°F)
- The device must meet the following minimum standards for military and aeromedical use:
- Electromagnetic Compatibility: Must meet MIL-STD-461G for Electromagnetic Interference (EMI) and Compatibility (EMC).
- Aeromedical Certification: Must be certified as "Safe-to-Fly" for use in military and commercial air transport.
- FDA Clearance: The device must have current FDA clearance for the indicated uses.
- Technical Considerations: The device must be capable of wired data connectivity. While a non-standard serial port is acceptable, it must be supplied with an appropriate adapter to ensure connectivity with modern computer systems (e.g., USB).
- Consumables: Please specify if the infusion pump system requires proprietary consumables (e.g., administration sets).
- Performance Testing: The device will be subject to a series of performance checks measuring the Volume to be Infused (VTBI) to validate accuracy and reliability.
- Submission: In response to this request for information, vendors shall submit a capability statement or white paper demonstrating that the proposed items meet all outlined specifications. Submissions must be received by the date specified in the SAM.gov announcement and submitted to the point of contact identified therein.
